QA Compliance Lead: Quality Risk & Recalls
Sarepta Therapeutics Inc
Sarepta Therapeutics seeks a Sr. Manager, QA Compliance to drive GMP/GxP quality systems and data-driven improvement. You will partner across QA operations, QC, manufacturing, MS&T, and external vendors to trend product data and address adverse trends. You’ll own Product Complaints and the Product Recall process while ensuring regulatory readiness. Ideal candidates bring US/ EU GMP knowledge, strong communication, and a proven ability to lead cross‑functional initiatives in a fast-paced #J-18808-Ljbffr Sarepta Therapeutics
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the QA Compliance Lead: Quality Risk & Recalls in Bedford, MA vacancy
$170k - $218k
...Director of Quality AssuranceThe Director of Quality... ...Assurance will oversee GMP QA operations for both... ...to supporting clinical compliance to GCPs and Inspection... ...regulatory requirements.Lead the development, implementation... ...testing partners.Drive risk management initiatives,...QualityRiskContract workAgenus
Lexington, MA4 days ago$136k - $170k
...the Role The Sr. Manager, QA Compliance, maintains GxP quality systems processes and procedures... ...of the Sarepta Product Recall process along with... ...with applicable SMEs and leads error prevention and continuous... ...to identify adverse trends/risks to drive continuous improvement...QualityRisk$180k - $200k
...Regulatory Affairs Manager to lead and evolve our post-market... ...including adverse event reporting, recalls, and compliance with international market... ..., working closely with Quality and Compliance teams Serve as... ...stakeholders, ensuring regulatory risk is communicated clearly and...QualityRiskFull timeContract workRemote work$1,000 per month
...contact center services. Lead process improvement,... ...that drive efficiency, quality, customer satisfaction,... ...strong controls and compliance. Collaborate with technology... ...banking regulations, risk management, and... ..., termination, layoff, recall, transfer, leaves of absence...QualityRiskFull timePart timeLocal areaFlexible hoursReading Co-Operative
Wakefield, MA25 days ago- ...negotiation through execution, compliance, and renewal. You will partner... ...objectives, while minimizing risk and maintaining regulatory compliance... ...to success in this role. Lead and oversee the negotiation,... ...and supply agreements, quality agreements, licensing and collaboration...QualityRiskContract workWork at officeLocal area
MBX Biosciences
Burlington, MA1 day ago $134k - $213k
Job Title Senior Quality Operations Manager-Advanced Imaging Job Description... ...processes and ensuring compliance with regulatory standards and... ...of products/services, often leads a cooperative effort among project... ...quality systems, ensuring risk management, and driving significant...QualityRiskFull timeWork at officeLocal areaImmediate startWork visaRelocation package3 days per week- Monogram Foods in Massachusetts is seeking a Quality Assurance Sanitation Supervisor to support QA and Sanitation teams in implementing plant policies and procedures... ...will supervise staff, ensure SQF, HACCP, QMS, GMP compliance, review inspections, documentation, and coordinate...QualityAfternoon shift
- Philips in Cambridge, MA is seeking a QMS Manager to lead the QMS team and drive compliant quality management across processes. You will oversee document... ...control, training, internal audits, CAPA, NCR handling, and risk management, ensuring alignment with medical device...QualityRisk
$115.1k - $143.9k
...better way. You will experience these qualities of passion, pride and aspiration... ...a Sr. Finance Manager, Corporate Risk & Trade Finance at AspenTech, you will lead the company's coordination of... ...across Finance, Treasury, Legal, Compliance, Sales, Commercial Finance, and Project...QualityRiskContract work- Responsible for maintaining quality standards for Ocular’s pharmaceutical and medical device... ...the Sr. Director of Quality Systems and Compliance. Principal Duties and Responsibilities... ...including vendor selection and corresponding risk evaluation. Collaborate in cross-...QualityRiskFull time
- Moderna is seeking a Manager, Risk-Based Quality Management (RBQM) to lead risk-based quality programs in clinical trials, ensuring patient safety, data integrity, and regulatory compliance through RBQM, risk management, central monitoring, and monitoring oversight. This...QualityRisk
- ...Executive Director, Quality Compliance About the Company Innovative pharmaceutical company specializing... ...GxP compliance framework. This includes leading and developing the Quality Compliance team, establishing and maintaining a risk-based approach to compliance oversight,...QualityRisk
- Werfen is seeking a Commodity Manager to lead procurement initiatives for electrical and... ...relationships, and cost optimization while ensuring compliance with quality and regulatory standards. The role emphasizes supply continuity, risk mitigation, and collaboration with...QualityRisk
- ...collaborating with them to dynamically mitigate safety, financial, quality, and sustainability risks during capital projects and facilities maintenance.... ...as they modernize contractor management, safety, and compliance programs across complex construction environments. This...QualityRiskFor contractorsFor subcontractor
Highwire
Burlington, MA4 days ago - ...-stage clinical trials, with a focus on quality, timelines, budget, vendor performance,... ...managing timelines, resources, budgets, risks, and quality.Provide operational leadership... ....Ensure studies are conducted in compliance with Company SOPs, ICH-GCP, FDA requirements...QualityRiskContract work
Clinical Dynamix
Burlington, MA4 days ago $120k - $140k
...dynamically mitigate safety, financial, quality, and sustainability risks during capital projects and... ...contractor management, safety, and compliance programs across complex construction... ...compliance, and project management teams. Lead recurring business reviews and strategic...QualityRiskPermanent employmentFull timeFor contractorsFor subcontractorWork at officeAlcumus
Burlington, MA2 days ago- ...spanning firmware, embedded configuration tools, clinical monitoring apps, and cloud infrastructure. The Design, Process, and Software Quality Risk Specialist will own the organizational risk management system across design, development processes, and software, with software...QualityRiskImmediate start
- Draper in Cambridge, MA is seeking a Quality Analyst to support quality control and assurance, ensure compliance, and help drive continuous... ...environment. The incumbent will lead sub-tasks, develop presentations, and coordinate risk reviews while maintaining high standards...QualityRisk
$90k
...Publishing is seeking a Quality Assurance/Operations... ...will focus on Aspen’s QA and Platform administration... ...Analyst REPORTS TO Lead Technical Product Manager... ...platform Flag quality risks or regressions proactively... ...and WCAG compliance a plus Familiarity with...QualityRiskWork experience placementWork at officeWork from homeNight shift$115k - $130k
...a collaborative environment leading to excellent outcomes. We have... ...Partner with Clinical, R&D, Quality, Medical Affairs, and other cross... ...identifying and escalating risks or potential delays. Support... ...technical documentation, GSPR compliance, UDI/EUDAMED data, and...QualityRiskBRIOHEALTH SOLUTIONS INC
Burlington, MA3 days ago- Draper in Cambridge, MA, seeks a Quality Analyst to support quality control and assurance programs. You will analyze data, document processes... ...role requires a bachelor’s degree and at least 3 years of QA experience, with the ability to obtain a DOD security clearance....QualityRiskContract work
- This Clinical Quality Assurance Senior Leader provides... ...quality programs to ensure compliance across global clinical... ...implements and manages risk-based quality systems,... ...experienced Clinical QA Senior leader who can build... ...and compliance, and leads the Alkermes strategy...QualityRiskContract work
$102.48k - $163.97k
Job Title Software Design Quality Engineer Job Description The Software... ...ensuring their accuracy and regulatory compliance throughout the software lifecycle. Your role: Leads the assessment of software... ...- Software design/verification, Risk management, Systems validation,...QualityRiskFull timeWork at officeImmediate startWork visaRelocation package3 days per week$200k - $260k
...vision is to build a world leading oncology company... ...Director/Senior Director, GMP Quality Assurance Operations.... ...supply demand. Lead QA input into CDMO... ...assigned programs, including risk-based qualifications, audits... ..., DMS, LMS), ensuring compliance with Part 11 / Annex 11...QualityRiskContract workTemporary workFlexible hoursCrescent Biopharma
Waltham, MAa month ago$160k - $175k
Join to apply for the Sr. QA Manager role at Piper Companies... ...is seeking a Senior Quality Assurance Manager to lead quality assurance efforts... ...Manager is pivotal in ensuring compliance with regulatory standards... ..., field actions, product recalls, site QMS documentation,...QualityFull time- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid) Overview... ...drive phase-appropriate GMP compliance across a growing modality... ...Key Responsibilities Build and lead a high-performing QC... ...for product lifecycle planning, risk assessments, fusion protein engineering...QualityRisk
- Meridian Bioscience, Inc. is seeking a Senior Quality Assurance Engineer in North Billerica, MA to ensure product quality from design to... ...manufacturing. You will join the Quality & Regulatory Affairs team, driving risk management, design controls, and CAPA implementation to meet FDA...QualityRisk
$250k - $273k
...investigational medicines, anchored by its lead product, ARCALYST, the first and only... ...it most.We're seeking a Senior Director, Quality Compliance reporting to the VP, Head of Quality,... ...cross-functionally to drive a proactive, risk-based quality culture that supports development...QualityRiskWork at office$38.11 - $98.23 per hour
...of care. Supports patient transitions, compliance, quality improvement, and regulatory standards while... ...level of care for patients. Leads the healthcare team in selecting appropriate... ...regarding medically fragile and or high risk patients admitted to the clinic. Identifies...QualityRiskHourly payFull timeTemporary workMonday to FridayShift workWeekend work$128k - $142k
...Clinical Operations Team, Clinical Development Lead and Medical Affairs as well as the... ...along key metrics, including key risks and challenges, to Senior Management and... ...range of peopleSite monitoring and clinical quality compliance experience are strongly preferredExcellent...QualityRiskInterim roleLocal areaRemote workNight shiftKiniksa Pharmaceuticals
Lexington, MA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to QA Compliance Lead: Quality Risk & Recalls. Be the first to apply!
