Senior Manager, Quality Document Control and Compliance

At Olema Oncology, we are committed to innovating and advancing the field of breast cancer treatment and beyond. Our flagship program, palazestrant (OP-1250), is a pioneering complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer, showcasing significant potential as both a standalone therapy and in combination with other treatments for ER+/HER2- metastatic breast cancer. Additionally, our subsequent product candidate, OP-3136, is a KAT6 inhibitor that stands out as best-in-class.We believe that our scientific achievements are propelled by a collaborative environment where we support, inspire, and challenge each other. At Olema, prioritizing the well-being of our team translates into exceptional results. If you are ready to be part of a transformative journey that deeply impacts the lives of our patients and enhances your career, we invite you to join us.For more insights, please check our latest corporate presentations here.About the Role: Senior Manager, Quality Document Control and ComplianceThe Senior Manager of Quality Document Control and Compliance will be a key player in our operations, reporting directly to the Director of Quality Systems. This role will oversee the daily operations of Veeva Vault QDocs, leading document management processes and ensuring compliance standards are met. Responsibilities include but are not limited to the creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs), and GXP documentation, as well as overseeing GXP record processing and archival. You will also be responsible for maintaining document control compliance KPIs and generating metrics for management review.This position is based in our Boston, Massachusetts office and may require approximately 15% travel.Your primary responsibilities will encompass:Acting as the Veeva Vault QDocs Administrator and document control manager.Processing document change control (DCC) for GxP controlled documents in Veeva.Formatting finalized documents to adhere to effective templates.Proofreading and finalizing documents for processing in Veeva QDocs.Collaborating closely with various functional areas to develop, update, manage, and maintain GxP controlled documents.

Join Ramboll as a Managing Consultant specializing in Air Quality Compliance and Permitting, with a focus on the Chemical and Pharmaceutical sectors. In this pivotal role, you will leverage your expertise to guide clients through complex regulatory landscapes while ensuring adherence to environmental standards. Your contributions will not only influence compliance strategies but also promote sustainable practices within the industry.

Join Olema Pharmaceuticals as a Senior Manager, Clinical Compliance & Inspection Readiness, where you will play a pivotal role in ensuring our clinical operations meet the highest standards of compliance and readiness for inspections. You will lead initiatives that drive adherence to regulatory requirements and best practices, helping us bring innovative therapies to patients efficiently and safely.

Accordion is hiring a Senior Quality Engineer to help maintain and improve quality across products and services. This position is based in several major cities, including Atlanta, Boston, Charlotte, Chicago, Dallas, Los Angeles, New York, and San Francisco. Role overview This role centers on upholding high quality standards throughout the development process. The Senior Quality Engineer works with teams from different disciplines, contributing expertise in quality assurance and process improvement. What you will do Create and execute detailed test plans to validate product and service quality Work closely with cross-functional groups to identify and document defects Support continuous improvement by sharing insights and recommending process changes Location Positions are available in Atlanta, Boston, Charlotte, Chicago, Dallas, Los Angeles, New York, and San Francisco.

Join our team as a Hindi Document Review Attorney, where you will engage in complex document review tasks remotely. This role involves conducting privilege and responsiveness reviews, implementing redactions, performing conceptual searches, and executing first and second reviews.Position Details:Location: RemoteStart Date: Negotiable

Join our team as a Korean Document Review Attorney and utilize your legal expertise in a dynamic remote environment.Position Overview:As a Korean Document Reviewer, you will engage in critical document review tasks, focusing on privilege and responsiveness assessments, redactions, and conceptual searching.Key Responsibilities:- Conduct thorough document reviews, ensuring compliance with legal standards.- Utilize electronic document review technologies, including Relativity and Concordance.- Collaborate with a team of legal professionals to streamline workflows.Experience & Qualifications:- Proficiency in Korean is essential.- Familiarity with document review processes and technology.- Active bar admission in at least one U.S. jurisdiction, maintaining good standing.Preferred Skills:- Experience working with document review teams.- Knowledge of Relativity version 9.0 or higher.- At least 2 years of experience in legal support roles.Work Environment:- This position offers remote work flexibility, with hours determined on a project basis.About Contact Review:Contact Review is dedicated to providing top-tier legal staffing solutions, specializing in document review and related services. Our culture emphasizes teamwork and efficiency, ensuring our clients receive the best possible support. For more information about our services, please visit https://contactdiscoveryservices.com/managed-document-review/.

Join the InterSystems IRIS® Data Platforms Cloud team as a Senior Quality Development Engineer, where your skills will directly impact the quality and robustness of our software solutions. In this role, you will play a pivotal part in identifying vulnerabilities and enhancing the performance of our products. Your passion for software development will drive you to create innovative tools and automation processes that not only validate new technologies but also ensure that existing features remain uncompromised. Your technical expertise, eagerness to learn, and creative problem-solving abilities are vital to our commitment to innovation.Duties and Responsibilities:Design and implement automated functional, load, and stress tests for InterSystems products in a multi-cloud environment, focusing on configurations and data representative of actual customer systems.Develop comprehensive test scenarios, author detailed test plans, and execute them effectively.Work collaboratively with cross-functional teams to provide timely feedback on newly developed features.Champion product quality by advocating for the customer’s perspective and ensuring that our solutions meet their needs.Analyze product source code to inform the design of edge and stress test cases, particularly for critical areas like failover and recovery.Review and verify documentation for clarity and conciseness, ensuring procedures are easy to follow.

Join our dynamic team as a German Document Review Attorney focused on contract review and document analysis.Location: RemoteStart Date: Negotiable EXPERIENCE & QUALIFICATIONS:Fluency in German is required.Familiarity with various document review workflows, including privilege/responsiveness review, redactions, and conceptual searching.Experience with electronic document review technologies such as Relativity, Concordance, or ViewPoint.Active bar admission in at least one U.S. jurisdiction and a status in good standing. PREFERRED SKILLS:Experience as a member of a document review team is a plus.Familiarity with Relativity version 9.0 or higher is advantageous.2+ years of legal support experience. WORKING CONDITIONS:Location (including remote work opportunities) is determined on a project basis.Work hours (including the flexibility to work outside standard business hours) are also defined on a project-by-project basis. ABOUT CGS Federal:CGS Federal is dedicated to providing high-quality legal support through our team of barred attorneys tailored to meet the specific needs of each project. Our culture emphasizes collaboration and efficiency, ensuring our clients are well-prepared to navigate any challenges. To learn more about CGS Federal, please visit our website: https://www.cgsfederal.com/

CGS Federal is hiring an English Document Review Attorney to handle legal document review projects for a range of clients. This position emphasizes careful, high-quality legal review and support across varied assignments. Location and Schedule Remote work is available, though project locations may change based on client needs Start date can be arranged to fit availability Flexible scheduling, including possible work outside standard business hours Key Responsibilities Assess documents for privilege and responsiveness Apply redactions when required Use conceptual search tools to find relevant materials Engage in all steps of the document review process Requirements Active bar membership in good standing in at least one U.S. jurisdiction Experience using electronic document review platforms such as Relativity, Concordance, or ViewPoint Preferred Qualifications Experience working on document review teams Knowledge of Relativity version 9.0 or newer Minimum of 2 years in legal support roles CGS Federal provides legal support tailored to a variety of project needs, focusing on efficient processes and workflow improvements. For more information, visit https://contactdiscoveryservices.com/managed-document-review/.

At Veeva Systems, we are dedicated to our mission of transforming the life sciences sector by providing innovative cloud solutions that accelerate the delivery of therapies to patients. As one of the fastest-growing SaaS companies in the world, we achieved over $2 billion in revenue last year and have exciting growth prospects ahead.Our core values drive us: Integrity, Customer Success, Employee Success, and Agility. In 2021, we became a public benefit corporation, ensuring that we consistently balance the needs of our customers, employees, society, and investors.Embracing flexibility, we are a Work Anywhere organization, allowing our employees to choose whether to work from home or the office to foster their success.Join us in our mission to revolutionize the life sciences industry, making a meaningful impact on our clients, team members, and communities.Position OverviewWe are seeking a seasoned consultant to spearhead MedTech Complaints management implementations for our global MedTech clientele. This role is pivotal in guiding the enhancement of our customers’ Complaints Management systems and technological frameworks. The MedTech Complaints consultant will collaborate closely with our Professional Services teams to ensure successful QMS implementations.

Whoop, Inc. is seeking a Senior Hardware Compliance Engineer based in Boston, MA. This role focuses on ensuring that hardware products meet all relevant compliance and regulatory standards. The position plays a key part in upholding quality and safety across the company’s devices. Role overview The Senior Hardware Compliance Engineer will work closely with product and engineering teams to confirm that each hardware release aligns with required regulations. Attention to detail and a strong understanding of compliance processes are essential for success in this position. What you will do Oversee compliance and regulatory requirements for hardware products Support efforts to maintain high standards of quality and safety Contribute expertise to help guide product teams through certification processes Requirements Experience with hardware compliance and regulatory standards Strong commitment to quality and safety in product development

At WHOOP, we are dedicated to enhancing human performance through advanced insights into individual health and daily activities. Our mission is to empower users to unlock their potential by understanding their bodies better.As a Senior Hardware Quality Engineer (NPI), you will play a pivotal role in collaborating with cross-functional teams, including Hardware Engineering, Manufacturing, Supply Chain, and Operations, as well as internal Quality Assurance teams. Your primary responsibility will be to ensure that new products meet rigorous quality standards throughout each development phase and are launched without significant quality issues. You will also liaise with external business partners to produce vital documentation, including Design Failure Mode & Effects Analysis (DFMEA), Critical to Quality (CTQ) specifications, DFx, and New Unique Different and Difficult (NUDD) analyses.

Join Whoop as a Senior Program Specialist in our Risk & Compliance Operations team. In this pivotal role, you will be responsible for developing and implementing compliance strategies that align with regulatory requirements while driving operational excellence. You will collaborate with cross-functional teams to ensure that compliance practices are effectively integrated into our workflows, safeguarding our organization’s integrity and reputation.

We are seeking a detail-oriented Contract Mandarin Document Review Attorney to join our dynamic team. This role will primarily focus on the review and analysis of legal documents in Mandarin.Position Overview:This position is remote and offers flexibility in working hours, which will be determined based on project requirements.

Join Veeva Systems, a trailblazer in the industry cloud space dedicated to accelerating the delivery of life-changing therapies to patients. As one of the fastest-growing SaaS companies, we achieved over $2 billion in revenue last fiscal year, positioning us for substantial future growth.At Veeva, our core values drive our success: Integrity, Customer Success, Employee Success, and Speed. We made history in 2021 by becoming a public benefit corporation (PBC), committing to balance the needs of our customers, employees, society, and investors.As a Work Anywhere organization, we empower you to choose your optimal work environment, whether at home or in the office.Be part of our mission to transform the life sciences industry and create a lasting positive impact on our customers, employees, and communities.The RoleWe are seeking a seasoned Senior Product Manager to enhance the efficiency and productivity of our customers in delivering life-saving medicines and treatments. You will take charge of designing and implementing our primary access control framework utilized by all Vault applications. Your contributions will not only affect millions of end users but also secure essential data and documents across the Vault platform.

Join Artech Information Systems LLC as a Documentation Specialist I in Boston. In this pivotal role, you will assist in creating, editing, and maintaining essential documentation for our projects. Your contributions will ensure clarity and consistency across various documents, aiding our teams in delivering exceptional service to our clients.

Join Whoop as a Senior Risk & Compliance Analyst, where you will play a crucial role in developing robust risk management strategies and ensuring compliance across our operations. You will collaborate with cross-functional teams to identify potential risks and implement effective solutions. Your expertise will directly contribute to maintaining our commitment to integrity and excellence.

InterSystems Corporation is hiring a Senior Quality Development Engineer in Boston, MA. This role sits at the intersection of software quality and healthcare technology, supporting products that help transform patient care worldwide. Role Overview As a Senior Quality Development Engineer, join a cross-functional agile team focused on ensuring quality throughout the entire product lifecycle, from initial design through final validation. The team includes developers and application specialists who work together to deliver reliable, user-friendly healthcare solutions. What You Will Do Maintain and improve product quality, performance, and usability across all development phases Collaborate closely with technical professionals to deliver products that support better patient outcomes Apply technical skills and modern tools to test and validate healthcare software Contribute to agile development cycles and shared team goals About the Products InterSystems' flagship product, TrakCare, is a unified healthcare information system used in over 25 countries. It enables coordinated care by giving clinicians and administrators a complete view of patient histories and secure record access at every stage of care. TrakCare helps organizations improve safety, reduce costs, minimize errors, speed up billing, and use resources more effectively. The Personal Community solution further supports patient engagement for both TrakCare and HealthShare users worldwide. TrakCare is built on the HealthShare informatics platform, which ensures interoperability and provides real-time analytics for informed decision-making. Why InterSystems? Work on products that directly impact healthcare organizations and patient outcomes Collaborate with a global network of skilled, technically minded professionals Access extensive training, development tools, and expertise available within a large organization Grow professionally in a company with a strong reputation in healthcare IT

We are seeking a skilled Bilingual French Document Review Attorney to join our team remotely. This role involves conducting thorough document reviews, including privilege and responsiveness assessments, redactions, and conceptual searches. Key Responsibilities:Conduct document reviews for legal proceedings.Perform privilege and responsiveness assessments.Manage redactions and ensure compliance with legal standards.Utilize electronic document review technologies effectively. Start Date: Negotiable

Join Veeva Systems, a trailblazer in industry cloud solutions, dedicated to accelerating the delivery of therapies to patients. As one of the most rapidly growing SaaS companies, we achieved over $2 billion in revenue last fiscal year, with significant growth prospects on the horizon.At Veeva, our core values drive us: Do the Right Thing, Customer Success, Employee Success, and Speed. In 2021, we made history by becoming a public benefit corporation (PBC), committed to balancing the needs of our customers, employees, society, and investors.As a Work Anywhere company, we empower you to work flexibly from home or the office, fostering an environment where you can thrive.Become a part of our mission to transform the life sciences industry, and make a meaningful impact on our customers, employees, and communities.The RoleAre you driven by a passion for continuous innovation and building lasting customer relationships? Do you excel at solving large-scale, complex challenges? Veeva Systems is seeking motivated Professional Services Consultants who are enthusiastic about empowering enterprise clients with cutting-edge cloud technologies. Our Vault Quality solution enables organizations to break down silos and expedite the production of high-quality products, benefiting more patients globally. This cloud platform integrates applications, processes, and partners across content management, training, Quality Management Systems (QMS), and Quality Control lab solutions (LIMS). As a key member of our Professional Services team, you will analyze clients' existing business processes, define a future state vision, identify and integrate global regulatory requirements, translate business needs into solution designs, and establish global strategies for deploying our cloud solutions across enterprises. This position is a remote, full-time, permanent role with no specific location requirement. It is customer-facing, with occasional travel of up to 50% expected.