Quality assurance manager jobs in Massachusetts - 697 jobs

Your mission The Commercial Quality Assurance Director will be based in Massachusetts and serve as the primary QA contact for commercial operations in the United States, maintaining close alignment with key partners in the United States and Europe. The position requires strategic leadership in developing and expanding a global Quality Management System, as well as extensive knowledge of GMP compliance and regulatory requirements. The Commercial Quality Assurance Director will also manage relationships with external partners, including CMOs, 3PLs, and distributors. The Commercial Quality Assurance Director will also oversee the quality of GMP development partners to ensure seamless integration across the product lifecycle. As we prepare for the launch of pritelivir in 2026, the Commercial Quality Assurance Director will play a critical role in supporting FDA inspection readiness and EMA submission activities while driving quality excellence across global operations. Lead the creation, review, and revision of SOPs to ensure commercial readiness and regulatory GMP compliance. Shape the evolution of the QMS to meet global commercial and regulatory GMP expectations. Implement recall procedures and perform mock recall to ensure recall procedures are adequate. Review, negotiate, maintain and manage quality agreements with CMOs, 3PLs, wholesalers and distributors. Serve as the primary QA contact for external commercial partners (e.g., CMOs, 3PLs, wholesalers, distributors). Develop and deliver training programs on commercial and GMP QA processes across all levels of the organization. Provide strategic oversight of GMP compliance across all outsourced manufacturing and packaging activities. Act as the QA liaison with internal stakeholders (e.g., Supply Chain, CMC, and Regulatory Affairs) and external service providers. Drive vendor qualification, audit strategy, and ongoing performance management. Lead / support internal and external audits, as required. Ensure inspection readiness for the FDA and support EMA submission activities within your area of responsibility. Prepare, review, and/or approve high-impact quality documentation, including batch records, deviations, CAPAs, change controls, product complaints and product quality reviews. Support product release processes and ensure timely QA support for supply chain operations. Drive continuous improvement initiatives within the commercial/GMP QA framework. Your profile Bachelor's, master's, or doctoral degree in a relevant scientific discipline (e.g., biology, chemistry, or pharmacy). Minimum 7 years of experience in biotech/pharma with exposure to commercial products. Deep understanding of FDA regulations (21 CFR Parts 210/211 and 600) and EU GMP (EudraLex, Volume 4) and global commercial quality standards. Proven experience in building and scaling QMS for commercial operations. Ideally, experience with computerized system validation in a GxP-regulated environment. Strong strategic thinking, communication, and stakeholder management skills. Detail-oriented with strong analytical and problem-solving abilities. Experience working in global regulatory environments and managing international QA operations is a plus. Ability to travel occasionally for audits, inspections, and team meetings. Close collaboration and alignment with the global QA team in Germany. Fluency in English. Why us? Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration. Development: We encourage people to grow and strongly support individual development and learning opportunities. Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life. Benefits: Competitive comprehensive benefit plan. #J-18808-Ljbffr

Monte Rosa Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs through participation on in-house and external cross-functional teams. This role requires an 75% on-site presence. You will work closely with industry leaders in Boston and Basel . Join a diverse, collaborative, and dynamic team that values innovation, teamwork, and a people-centric culture! Responsibilities Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs as well as other GCP quality events (e.g., potential serious breach assessments, CAPAs) Author key GCP quality SOPs and key reviewer for other quality (GxP) procedures. Develop a risk-based GCP compliance program. Support teams in the initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans. Develop and provide GCP and other GxP training (as applicable). Ensure appropriate qualification of vendors and ensure compliant vendor management and regular assessment/audits. May conduct GCP audits (vendors and sites). Ensure audit observations are communicated, tracked and remediated. Provide QA GCP review and feedback on regulatory submissions. Lead and participate in inspection readiness activities for regulatory inspections - both internally and at clinical sites. Interface with internal departments and external vendors on a variety of technical/quality subjects. Qualifications BS Degree in Chemistry, Pharmacy, Biology or a related life science, or a combination of a BS Degree with relevant Quality and Technical experience. Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations. Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience a plus. Able to provide solution-minded approach and flexibility to emerging challenges. Able to appropriately balance priorities plus multi-task against competing priorities. Proven experience with the desire, and ability to work in a fast-paced, matrixed, start-up environment. Hands-on leader, able to provide solution-minded approach and flexibility to emerging challenges Understanding of drug development and program management preferred. #J-18808-Ljbffr

A leading medical products company is seeking a Vice President of Global Quality Assurance and Regulatory Affairs in Boston. The successful candidate will lead QA/RA efforts, ensuring compliance with FDA and international standards while collaborating with teams across the organization. Candidates should have over 10 years of relevant experience in the medical field, strong leadership skills, and a proven track record in regulatory affairs. This full-time position offers competitive compensation and a suite of benefits. #J-18808-Ljbffr

A biopharmaceutical innovator is seeking a PV Quality and Compliance Associate Director. This critical role focuses on ensuring regulatory compliance in pharmacovigilance activities. The successful candidate will lead the development of the Quality Management System and manage audits. Requires a strong background in PV regulations, leadership skills, and experience in compliance initiatives. The position offers a competitive salary range of $150,000-$200,000 based on experience and location in Greater Boston. #J-18808-Ljbffr

**JLL empowers you to shape a brighter way**.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong. Whether you've got deep experience in commercial real estate, skilled trades or technology, or you're looking to apply your relevant experience to a new industry, join our team as we help shape a brighter way forward.**Candidate will be based in Boston, MA or Fairfield, NJ****What this job involves**The Quality Director serves as a strategic quality leader responsible for shaping the account's reputation and driving quality culture transformation. This role oversees the implementation, maintenance, and continuous improvement of comprehensive Quality & Compliance Programs for GxP-regulated facilities. The position requires extensive collaboration with client quality units, account teams, and third-party vendors to ensure regulatory compliance, audit readiness, and superior service delivery performance that meets contractual obligations and industry standards.**Your day-to-day tasks will include:*** Strategically develop, implement, and direct quality programs including non-conformance investigations, CAPAs, training compliance, and vendor qualifications to ensure deliverables meet or exceed expectations* Manage GxP third-party vendor compliance programs encompassing qualification processes, quality agreements, audits, and performance monitoring* Interface directly with client quality personnel to ensure adherence to established Quality Agreements and proper documentation per ALCOA+ guidelines* Develop trend analysis reports and maintain comprehensive infrastructure and compliance documentation to support regulatory requirements and audit readiness* Supervise, mentor, and train team members while collaborating with account-wide teams to share learnings, successes, and best practices* Ensure proper implementation of JLL's Life Sciences Quality Management System and ISO 9001:2015 requirements while actively participating in the Life Sciences Quality Council* Prepare and submit periodic account status reports related to Quality Programs and continuously improve processes to enhance client satisfaction**Physical Demands and Work Environment:*** Office environment with standard business hours and occasional extended hours during audits or critical projects* Frequent computer use requiring proficiency with multiple software applications and quality management systems* Regular meetings and presentations requiring clear verbal and written communication* Occasional travel to client sites, vendor facilities, or other JLL locations may be required* Ability to work in a dynamic team environment with minimal supervision* May require working in GxP-regulated manufacturing environments following safety protocols**Required Qualifications:*** Bachelor's degree in science* Minimum 15 years of experience in quality engineering, facilities design, and production/facility operations (strong related experience may substitute for degree)* Proven experience in strategic quality and regulatory leadership for GxP facilities from operations, facilities, and maintenance perspectives* Thorough understanding of international cGxP regulations as they relate to facilities, utilities, equipment, and laboratories supporting drug product manufacturing* Direct experience working at FDA-regulated manufacturing facilities in quality assurance or quality control capacity with solid GxP regulatory background* Strong knowledge of ISO 9001:2015 standard requirements and implementation* Proven leadership skills to effectively direct and sustain compliant, ethical, and quality culture environments* Demonstrated excellent internal and external customer service experience with proven track record* Knowledge of Quality Engineering techniques including investigations, root cause analysis, CAPAs, audit programs, vendor qualification, and change control processes**Preferred Qualifications:*** Working knowledge of Quality Management Software such as TrackWise, MasterControl, Success Factors, or Infinity systems* Proficiency in Microsoft Office applications, particularly Excel, Word, and PowerPoint for report preparation and data analysis* Experience with technical report preparation and analysis for regulatory compliance and contractual responsibility verification* Strong oral and written communication skills with ability to interface effectively across all management levels and diverse technical/non-technical customer base* Self-motivated and detail-oriented professional comfortable working independently with minimal supervision This position does not provide visa sponsorship. Candidates must be authorized to work in the United States without employer sponsorship.**Estimated compensation for this position:**136,000.00 - 170,000.00 USD per year*This range is an estimate and actual compensation may differ. Final compensation packages are determined by various considerations including but not limited to candidate qualifications, location, market conditions, and internal considerations.***Location:**Remote -Boston, MA, Parsippany, NJIf this job description resonates with you, we encourage you to apply, even if you don't meet all the requirements. We're interested in getting to know you and what you bring to the table!**Personalized benefits that support personal well-being and growth:**JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits may include:* 401(k) plan with matching company contributions* Comprehensive Medical, Dental & Vision Care* Paid parental leave at 100% of salary* Paid Time Off and Company Holidays* Early access to earned wages through Daily Pay***JLL Privacy Notice***Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLL's recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely.For more information about how JLL processes your personal data, please view our .For additional details please see our career site pages for each country.For candidates in the United States, please see a full copy of our Equal Employment Opportunity policy .Jones Lang LaSalle (“JLL”) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process - including the online application and/or overall selection process - you may email us at ******************. This email is only to request an accommodation. Please direct any other general recruiting inquiries to our page > I want to work for JLL.Pursuant to the Arizona Civil Rights Act, criminal convictions are not an absolute bar to employment.Pursuant to Illinois Law, applicants are not obligated to disclose sealed or expunged records of conviction or arrest.Pursuant to Columbia, SC ordinance, this position is subject to a background check for any convictions directly related to its duties and responsibilities. Only job-related convictions will be considered and will not automatically disqualify the candidate.**California #J-18808-Ljbffr

Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: This role provides Quality Assurance (QA) support for bioconjugation processes and GMP manufacturing of APIs and intermediates, ensuring compliance with global quality standards and regulatory requirements. This role will oversee key quality activities including deviation management, change control, batch record review, and product disposition, while driving continuous improvement and compliance initiatives. As a leader within the Quality Operations team, the QA Supervisor will guide and develop team members, collaborate across functions, and shape the strategic direction of quality within the organization. Core Responsibilities: Lead Quality Assurance oversight for bioconjugation manufacturing, ensuring GMP production and release of conjugated APIs, linkers, and payloads meet client expectations, timelines, and quality standards. Provide hands-on QA support on the production floor during conjugation, purification, and filling operations to ensure compliance with cGMPs, SOPs, and company policies. Oversee the review and approval of deviations, change controls, CAPAs, batch records, specifications, and other controlled quality documentation. Coach, mentor, and develop QA staff, providing guidance on quality systems, compliance practices, and real-time problem solving. Drive operational excellence by aligning local QA initiatives with global objectives and promoting a culture of quality and compliance across the organization. Support audits, investigations, and regulatory inspections, ensuring timely follow-up and continuous improvement in processes and systems. Evaluate complex quality or cross-functional issues using a risk-based approach and ensure CDMO partners meet Quality Agreement and regulatory expectations. Prioritize and allocate QA resources effectively to meet business demands and production schedules. Serve as a key client interface for Quality topics, fostering strong relationships and clear communication on regulatory and quality matters. Contribute to organizational quality strategy by participating in forums, continuous improvement initiatives, and talent development efforts. Qualifications: Required Minimum 9 years of quality assurance (QA) experience in a GMP manufacturing setting, preferably within a CDMO or API/intermediate facility, with an undergraduate degree in engineering, science or related field; or a minimum 7 years of QA experience with a graduate degree in engineering, science or related field Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance Proven ability to drive complex projects from initiation to completion, with strong analytical, problem-solving, and attention-to-detail skills. Demonstrated experience working effectively both independently and in team settings, including prior people management or team leadership. Excellent communication, interpersonal, networking, presentation, and influencing skills to build and lead cross-functional relationships. Embodies and promotes Veranova's culture, fostering an inclusive, positive work environment and delivering exceptional business results. Strong collaborative mindset with the ability to motivate, develop, and inspire others while effectively managing priorities and responsibilities. Preferred Direct experience with bioconjugation processes (e.g., linker/payload attachment, conjugated intermediates) is strongly preferred. Familiarity with HPAPI handling and containment requirements a plus Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc. Salary Range: $125,000 - $140,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .

At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders. They evaluate compliance with regulations including assessing governance and risk management processes and related controls. In financial statement audit at PwC, you will focus on obtaining reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes the auditor's opinion. Enhancing your leadership style, you motivate, develop and inspire others to deliver quality. You are responsible for coaching, leveraging team member's unique strengths, and managing performance to deliver on client expectations. With your growing knowledge of how business works, you play an important role in identifying opportunities that contribute to the success of our Firm. You are expected to lead with integrity and authenticity, articulating our purpose and values in a meaningful way. You embrace technology and innovation to enhance your delivery and encourage others to do the same. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: Analyse and identify the linkages and interactions between the component parts of an entire system. Take ownership of projects, ensuring their successful planning, budgeting, execution, and completion. Partner with team leadership to ensure collective ownership of quality, timelines, and deliverables. Develop skills outside your comfort zone, and encourage others to do the same. Effectively mentor others. Use the review of work as an opportunity to deepen the expertise of team members. Address conflicts or issues, engaging in difficult conversations with clients, team members and other stakeholders, escalating where appropriate. Uphold and reinforce professional and technical standards (e.g. refer to specific PwC tax and audit guidance), the Firm's code of conduct, and independence requirements. The Opportunity As part of the External Audit team you are expected to lead the way as technology-enabled advisors who provide benefits through digitization, automation, and increased efficiencies. As a Manager you are expected to supervise, develop, and coach teams, manage client service accounts, and drive assigned client engagement workstreams by independently solving and analyzing complex problems to develop quality deliverables. This role requires knowledge in U.S. GAAP, U.S. GAAS, and PCAOB standards, and a CPA license. Responsibilities Lead as technology-enabled advisors in external audit Supervise, develop, and coach teams Manage client service accounts Drive client engagement workstreams Solve and analyze complex problems Develop top-quality deliverables Confirm adherence to U.S. GAAP, U.S. GAAS, and PCAOB standards Utilize digitization and automation for increased efficiencies What You Must Have Bachelor's Degree in Accounting 5 years of experience CPA license. International hires are required to hold the equivalent certification/credential in the selected individual's home country and will be required to meet US credential requirements after joining the firm. What Sets You Apart CPA license in work office state In-depth knowledge of U.S. GAAP and U.S. GAAS Proficiency in technical accounting and financial reporting Ability to lead and motivate teams Broad global and cross-cultural perspective Proficiency in automation and digitization Client relationship management skills Business acumen and industry knowledge Learn more about how we work: ************************** PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: *********************************** As PwC is anequal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion; national origin; sex (including pregnancy, sexual orientation, and gender identity); age; disability; genetic information (including family medical history); veteran, marital, or citizenship status; or, any other status protected by law. For only those qualified applicants that are impacted by the Los Angeles County Fair Chance Ordinance for Employers, the Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, San Diego County Fair Chance Ordinance, and the California Fair Chance Act, where applicable, arrest or conviction records will be considered for Employment in accordance with these laws. At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship to responsibilities such as accessing sensitive company or customer information, handling proprietary assets, or collaborating closely with team members. We evaluate these factors thoughtfully to establish a secure and trusted workplace for all. The salary range for this position is: $99,000 - $252,450. For residents of Washington state the salary range for this position is: $99,000 - $297,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. All hired individuals are eligible for an annual discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. To view our benefits at a glance, please visit the following link: *********************************** #J-18808-Ljbffr

Our client, an innovative biopharmaceutical company based in Boston, is seeking a Head of Quality Assurance to lead the overall QA function and ensure the highest standards of GMP compliance, product quality, and operational excellence across development and commercial activities. This individual will serve as the company's senior QA leader, responsible for setting the quality vision, overseeing GxP compliance, building and developing quality teams, and partnering closely with Manufacturing, CMC, Technical Operations, Supply Chain, and Regulatory Affairs. This is a high-impact, onsite leadership role ideal for a seasoned QA executive with strong GMP experience in biologics, advanced therapies, or other regulated modalities. Key Responsibilities Quality Leadership & Strategy Define, implement, and lead the company-wide Quality Assurance strategy in alignment with organizational goals and global regulatory expectations. Serve as the primary authority on QA standards, policies, and GxP compliance across all operations. Provide strategic oversight across GMP, Quality Systems, QA Operations, and Supplier Quality. GMP Compliance & Quality Systems Ensure full compliance with FDA, EMA, ICH, and global regulatory guidelines. Oversee development, maintenance, and continuous improvement of the Quality Management System (QMS). Lead GMP oversight of manufacturing operations, batch record review, and product release activities. Manage deviation investigations, CAPAs, change controls, and quality risk management processes. Manufacturing & Operational Quality Partner closely with internal and external manufacturing teams to ensure quality oversight throughout the product lifecycle. Support tech transfers, scale-up activities, comparability, and process validation from a QA perspective. Provide quality leadership for raw materials, suppliers, CMOs, and testing labs. Regulatory & Inspection Readiness Act as a key interface with regulatory agencies on quality-related matters. Lead site inspection readiness activities and manage responses to regulatory findings. Provide QA input into regulatory submissions, including Module 3 and GxP documentation. People Leadership & Organizational Development Lead, mentor, and build a high-performing QA team covering Quality Systems, QA Operations, Supplier Quality, and Quality Compliance. Establish clear expectations, training, and succession planning to support growth and scalability. Foster a culture of accountability, continuous improvement, and proactive quality thinking. Qualifications Education Bachelor's degree required; advanced degree (M.S., Ph.D., Pharm.D.) in a life sciences discipline preferred. Experience 12-18+ years of progressive experience in Quality Assurance within the biopharmaceutical industry. 7+ years in QA leadership roles managing teams and complex GxP operations. Strong background in GMP quality oversight, manufacturing operations, and QMS management. Experience working with biologics, cell & gene therapies, mRNA, or other complex modalities strongly preferred. Proven track record of inspection readiness and successful interactions with FDA, EMA, or other global authorities. Experience supporting clinical and/or commercial product quality. Skills & Leadership Attributes Deep understanding of global GxP regulations and industry standards. Exceptional communication, influencing, and leadership capabilities. Strong problem-solving skills with a proactive and solutions-driven mindset. Ability to work onsite and engage closely with lab, manufacturing, and technical teams. High integrity and commitment to patient safety and product quality. Additional Information Work Model: Fully onsite in Boston; daily leadership presence required. Travel: Occasional domestic or international travel to partners, CMOs, or regulatory meetings. Compensation: Competitive executive-level compensation including base salary, bonus, equity, and benefits.

Title: Quality Systems & Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams. Key Responsibilities • Lead real-time floor support, triaging deviations and initiating root cause investigations. • Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments. • Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions. • Apply structured scientific thinking to evaluate data and support operational decisions. • Contribute to process improvement by identifying trends and proposing optimized workflows. Qualifications • 6+ years experience in pharma/biotech manufacturing environments. • Proven background in investigations, RCA, QC analytics, and GxP documentation. • Skilled in cross-functional coordination and rapid issue assessment. • Strong analytical mindset with the ability to interpret complex data sets. • Experience supporting manufacturing operations in fast-paced, regulated environments. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$58/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.

Govern owned QMS applications, including harmonization of processes across sites. Responsible for requirements authoring and ongoing maintenance by leading and facilitating meetings/workshops with Site Process Owners and Key Users (Business SMEs). Approve validation deliverables including initial implementation and operational changes. Change ownership, including initiating and managing change through completion. Maintain system in a validated state, including periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with QMS. Lead and manage user forums for ongoing requirements gathering, prioritization, and triaging of issues. Lead and manage ongoing meetings with the vendor/IT as necessary. Report status and issues to governance committees/senior leadership. Communicate milestones and planned changes to user community promoting use of QMS. Responsible for representing owned QMS applications during inspections and explaining compliance. Train management and onboard new users to the system. Ensure Periodic Reviews (PR) are conducted per required frequency and approve PR Reports. Support Quality System Vendor Audits as a Business SME. Support KPI reporting and lead commitment meetings. Manage regular system updates/releases and assess and recommend new features. Ensure key user-related documentation is maintained and kept up-to-date as new functionalities are enabled, created and/ or modified. Investigate, escalated, and resolve issues identified on system. Execute/facilitate regression testing associated with system upgrades/project implementation. Participate in user forums/industry groups to garner best practice and represent Alkermes. Identify opportunities for continuous improvement and prioritize and manage associated change to completion. Qualifications Bachelor's degree in Computer Science, Engineering, or related field and five years of experience implementing and maintaining regulated systems. Experience must include five years each of the following: project management; development of user procedures; and SaaS (Software as a Service Solution)/cloud solutions. Experience must include one year each of the following:TrackWise Digital, ComplianceWire, and Veeva; system testing in a regulated industry; quality systems processes in commercial/clinical pharma/healthcare facility; US FDA, ICH guidelines, and European regulatory requirements; GAMP; and development of CBT (computer-based training) modules. Experience may be gained concurrently. The annual base salary for this position ranges from $141,000 to $146,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website:************************************* . #J-18808-Ljbffr

Pay Rate: $40-$50/hr Work Model: Hybrid (Onsite Tuesday, Wednesday, Thursday) The Quality Systems Specialist, under the direction of the QS&C management team, supports global Quality Systems to ensure compliance, operational effectiveness, and fitness for intended use in alignment with applicable global SOPs. Key Areas of Accountability Quality System Governance & Support Assist in governance of Quality System applications, including harmonizing processes across sites Participate in meetings/workshops with Site Process Owners and business SMEs to gather requirements for system improvements and ongoing maintenance Join user forums to collect ongoing requirements, prioritize needs, and triage issues Follow up on requests, issues, and project activities; provide status updates to managers and working teams Change Control & Compliance Initiate and manage change controls through completion, including all required documentation Ensure systems remain in a validated state by supporting periodic user access reviews, change management, business administration, and deviations/CAPAs Support investigation, escalation, and resolution of system-related issues Validation & Documentation Support validation activities, including: Requirements gathering Validation planning Design qualification Authoring and executing test plans and test scripts Discrepancy management Preparing system descriptions and validation summary reports Maintain user-related documentation and ensure updates as new functionalities are introduced Cross-Functional & User Support Assist manager with communication between vendor/IT teams Provide customer support through system administration, training management, and onboarding of new users Generate metrics to support Quality Systems performance Support regular system updates/releases and provide assessments and recommendations on new features Academic & Technical Qualifications Bachelor's degree or higher in a relevant computer, technical, quality, or scientific discipline (multi‑disciplinary background preferred) 3-6 years of experience in a high‑volume commercial or clinical pharma/healthcare environment Proficiency in MS Word, Excel, and Quality System processes Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus Strong understanding of US FDA and European regulatory requirements, GAMP, and phase‑appropriate compliance expectations Knowledge of Regulatory Compliance and ICH Guidelines General Comments Position Title: Quality Systems Specialist Pay Rate Range: $40-$50/hr

Please note our client does not Sponsor Job Role: IT-QA Work Hours: General: 8:00AM - 5:00PM (May vary based on business needs) Reports To: Site Quality Assurance Head Salary Range: $67,000 - $95,000 - PURPOSE The purpose of the IT - QA Associate position is to accurately review the chronological record of Laboratory Instrument/Equipment electronic data related activities that provides documented evidence of relevant details of specific events. JOB DESCRIPTION The IT- QA Associate position is an individual contributor role and a member of the Pharmaceuticals Quality Team. The position monitors changes to electronic records, alterations in critical parameters or any other actions that could impact product quality. This position reports to the Site Quality Head. The job duties for this position include but are not limited to the following: Function as SME for IT related activities of QMS platforms and other electronic systems including digital platforms which need compliance to 21CFR, Part 11 requirements. Conduct regular audits of the audit trail to identify any irregularities or potential issues. Additionally, routinely review and analyze the data to proactively address any emerging trends or areas for improvement. Provide comprehensive training to employees involved in the analytical laboratory related activities as well as manufacturing process who are entitled to use digital platforms for execution of GMP/GLP activities. Ensure that users understand the importance of audit trail integrity and data integrity and their role in maintaining accurate and reliable records and adhering to cGMP compliance. Provide support for investigation and implementation of CAPA related to such investigation. EDUCATION AND EXPERIENCE QUALIFICATIONS B.Sc. in a scientific discipline related to the pharmaceutical industry (Biology, Chemistry, Pharmacology, Biochemistry, etc). Basic knowledge and Industry experience of Quality System relevant to electronic records storage, retrieval, archival and audit of electronic data is must. Minimum of two (2) years' experience in a quality assurance in a GMP environment specific Quality Control Laboratory and Manufacturing operations in a pharmaceutical manufacturing organization. Experience in MDI or DPI dosage form manufacturing preferred. KNOWLEDGE, SKILLS, AND ABILITIES Candidates must have an aptitude for quantitative problem-solving or advanced analytics. Ability to multitask efficiently, prioritize quickly, and manage time effectively. Candidates must have experience in writing and executing performance tests. Database and computer skills; talent for analyzing and visualizing complex data. Advanced proficiency with Microsoft Excel. Must have current Good Manufacturing Practices (cGMP) knowledge. Must have strong attention-to-detail. Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed. Must have strong organization and communication skills (written, verbal, and presentation). Must be detail-oriented with the ability to prioritize tasks with strict deadlines.

A leading global energy management company seeks a dedicated individual for a software quality role to manage best practices and ensure quality processes. This position focuses on improving customer satisfaction through software quality initiatives and requires a strong background in software development over 15 years. The candidate should have extensive knowledge of software methodologies and effective leadership skills to drive change in software systems. This is a full-time role based in Boston, MA, which offers competitive compensation and a comprehensive benefits package. #J-18808-Ljbffr

IT Quality Systems Specialist in Pharma. Purpose The IT Quality Systems Specialist is responsible for the accurate review and oversight of electronic laboratory and equipment data to ensure data integrity, compliance, and traceability. This role provides documented evidence of system-related activities and events that may impact product quality, in alignment with cGMP and regulatory requirements. Job Summary The IT Quality Systems Specialist is an individual contributor and a key member of the Pharmaceuticals Quality Team. This role monitors and evaluates electronic records, audit trails, and system changes to ensure compliance with 21 CFR Part 11 and other applicable regulations. The position supports quality investigations, CAPA activities, and continuous improvement initiatives related to electronic data systems. The role reports directly to the Site Quality Head. Key Responsibilities Serve as a Subject Matter Expert (SME) for IT-related activities supporting Quality Management System (QMS) platforms and other regulated electronic systems requiring compliance with 21 CFR Part 11. Monitor and review audit trails and electronic records to identify irregularities, unauthorized changes, or trends that could impact data integrity or product quality. Perform routine analysis of electronic data to proactively identify risks, trends, and opportunities for process improvement. Provide training to laboratory and manufacturing personnel on the proper use of digital platforms supporting GMP and GLP activities, with emphasis on audit trail integrity, data integrity, and cGMP compliance. Support investigations related to electronic data issues and participate in the development and implementation of corrective and preventive actions (CAPAs). Collaborate cross-functionally with Quality, IT, Laboratory, and Manufacturing teams to ensure compliant system use and documentation practices. Education and Experience Qualifications Bachelor's degree (B.Sc.) in a scientific discipline related to the pharmaceutical industry (e.g., Biology, Chemistry, Pharmacology, Biochemistry). Minimum of two (2) years of Quality Assurance experience in a GMP-regulated pharmaceutical manufacturing environment, supporting Quality Control Laboratory and Manufacturing Operations. Working knowledge of quality systems related to electronic data generation, storage, retrieval, archival, and audit is required. Experience with MDI or DPI dosage form manufacturing is preferred. Knowledge, Skills, and Abilities Strong understanding of current Good Manufacturing Practices (cGMP). Experience reviewing electronic records and audit trails in regulated systems. Aptitude for quantitative problem-solving, data analysis, and advanced analytics. Experience writing and executing performance or system-related tests. Strong database, computer, and data visualization skills. Advanced proficiency in Microsoft Excel. Excellent attention to detail with the ability to prioritize and manage multiple tasks under strict deadlines. Self-motivated, proactive, and capable of working independently with minimal supervision. Strong organizational, written, verbal, and presentation communication skills. Additional Information On-site position; no remote work available. Relocation assistance may be negotiable. No employment sponsorship available.

Who We Are Strand Research is a biotechnology startup dedicated to developing and optimizing novel molecules for haircare applications to be launched in a new brand. Positioned at the crossroads of science and beauty, we are committed to innovation driven by rigorous data and relentless pursuit of efficacy, creating solutions that will set new industry standards and redefine what is possible in hair care. Our lab is based in Kendall Square and we have secured substantial funding, providing us with several years of runway to bring groundbreaking ingredients to market. We have made major progress on the science side, and are now looking for a R&D strategy manager to help turn that innovation into real, high-impact products. The ideal candidate is a results-driven, high octane, resourceful individual who thrives in a fast-paced, high intensity environment with a passion for science and consumer goods. You will partner directly with scientists and leadership to shape program strategy, define what “good” looks like, and help identify the most promising directions across our portfolio. You'll translate high-level scientific concepts into focused, achievable plans, ensuring that every project has clarity and momentum. We're looking for a sharp generalist with both strategic depth and executional grit, someone who can move fast, wear multiple hats, and help shape our research outcomes. What You Will Do Work with scientific leads to define hypotheses, sharpen project goals, and prioritize the programs with the highest potential impact Build clear, aggressive plans that translate research into focused milestones and decision points Help shape and execute our IP strategy, pulling in the technical narratives and experimental data to strengthen and accelerate our filings Deliver strategic updates that give leadership visibility into progress, roadblocks, and opportunities across the R&D portfolio Build and lead relationships with vendors, CROs, academic partners, and other external partners to accelerate progress to market Do whatever it takes to move our best leads through development and into market-ready products Who You Are 3-5+ years of full-time experience in consulting, finance, high-growth start-up, or similar high-intensity role Scientific degree or deep, self-driven interest in science A self-starter with a desire to win Disciplined and organized, with the ability to create structure for ambiguous problems Strong interpersonal skills with ability to manage many different stakeholders A “doer” and a thinker who is willing to get hands dirty in execution while maintaining a strategic mindset Strong analytical skills with a bias for insights and results Passionate about the intersection of science and the consumer Additional Information This position is hiring for an immediate start, with some flexibility for the right candidate This position is in-office in Cambridge, MA The salary for this position is commensurate with experience Interested? Reach out to learn more and apply at ************************

Aerospace & Defense Quality Engineer - 6-Month Contract The Quality Engineer will be responsible for the development, implementation, maintenance, and continuous improvement of quality assurance processes in a regulated aerospace and defense environment. This role requires a strong data-driven mindset and hands-on quality engineering expertise to ensure compliance with AS9100/ISO standards, customer requirements, and regulatory obligations. Responsibilities Identify, analyze, and resolve quality issues using structured problem-solving methodologies Perform loss reporting and drive continuous improvement initiatives Design and implement process control, process improvement, testing, and inspection methods Develop, execute, and analyze quality metrics and reporting to support data-driven decision-making Perform and review First Article Inspections (FAI) in accordance with AS9102 requirements Interpret and apply GD&T per ASME Y14.5 to support inspection planning, nonconformance resolution, and root cause analysis Ensure compliance with AS9100 and applicable ISO standards across manufacturing and inspection processes Support and participate in internal, customer, and third-party quality audits Collaborate cross-functionally with engineering, manufacturing, and supply chain teams to ensure quality requirements are met throughout the product lifecycle Qualifications Bachelor's degree in Mechanical, Electrical, Manufacturing Engineering, or a related field (or equivalent experience) 4+ years of quality engineering experience in aerospace, defense, or another regulated manufacturing environment Strong working knowledge of AS9100, ISO 9001, and aerospace quality system requirements Experience performing and reviewing First Article Inspections (AS9102) Proficiency in interpreting engineering drawings and GD&T per ASME Y14.5 Strong knowledge of industry quality tools (e.g., SPC, FMEA, root cause analysis, CAPA) Demonstrated analytical, data-driven approach to problem solving Strong communication, documentation, and audit-support skills To learn more or apply, please contact me at ****************************. BioTalent Ltd is acting as an employment agency in relation to this opportunity.

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role The Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market. Key Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling. Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities. Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards. Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records. Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success. Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays. Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions. Maintain rigorous laboratory documentation and complete, audit-ready analytical records. Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases. Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills. Qualifications Bachelor's degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1-3 years of relevant mechanical testing or QC experience, or a master's degree with applicable laboratory experience. Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems. Demonstrated proficiency in tensile, compression, shear, puncture, and force-displacement mechanical characterization. Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products. Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+). Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation. Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus. Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment. Excellent verbal and written communication skills and comfort working within interdisciplinary teams. Commitment to collaborative work within interdisciplinary project teams. At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .

Site: Mass General Brigham Health Plan Holding Company, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Responsible for overseeing and improving clinical performance metrics and ensuring compliance with healthcare regulations and accreditation standards. Collaborates with clinical teams to develop strategies for improving patient care outcomes and ensures that clinical operations align with regulatory and quality requirements. Essential Functions -Monitor and analyze clinical performance data to identify areas for improvement in patient care and outcomes. -Ensure compliance with all regulatory, accreditation, and quality standards across clinical operations. -Collaborate with clinical staff to implement performance improvement initiatives and ensure best practices in patient care. -Develop and maintain clinical performance dashboards and reports to track key metrics. -Coordinate with quality, compliance, and risk management teams to ensure alignment with organizational goals. -Provide training and education to clinical teams on performance improvement, regulatory compliance, and accreditation standards. -Conduct audits and assessments of clinical processes to ensure continuous quality improvement. -Work with leadership to set performance goals and develop action plans to achieve them. Qualifications Education Bachelor's Degree required; work experience can be substituted in lieu of a degree License/Certification Massachusetts Registered Nurse (RN) license highly preferred Experience At least 3-5 years of experience in clinical performance management, compliance, or quality improvement required Knowledge, Skills, and Abilities Knowledge of healthcare regulations, accreditation standards (e.g., Joint Commission), and clinical performance metrics. Strong analytical skills with the ability to interpret clinical data and identify improvement opportunities. Excellent communication and collaboration skills to work effectively with clinical teams and leadership. Detail-oriented with a strong understanding of healthcare regulations and accreditation standards. Proficiency in performance management software and tools for tracking clinical outcomes. Ability to lead performance improvement projects and implement evidence-based practices. Additional Job Details (if applicable) Working Conditions This is a remote role that can be done from most US states Remote Type Remote Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $78,000.00 - $113,453.60/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Health Plan Holding Company, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

A digital health technology company is seeking a Director of Regulatory Affairs and Quality Assurance to lead regulatory compliance and quality frameworks for their medical-grade digital health products. This role involves overseeing FDA submissions, ensuring quality management systems meet global standards, and mentoring a high-performing regulatory team. The ideal candidate will have a strong background in regulatory affairs, experience with medical devices, and the ability to thrive in a fast-paced environment. Competitive salary offered in Boston, MA. #J-18808-Ljbffr