Senior GMP Quality Assurance Operations Leader
Kiniksa Pharmaceuticals
Kiniksa Pharmaceuticals is seeking an Associate Director, GMP Quality Assurance Operations in Lexington, MA to oversee quality operations for GMP manufacturing activities supporting clinical programs. You will be responsible for quality oversight throughout the manufacturing process, including tech transfers and compliance with global regulatory standards. The ideal candidate will have at least 8 years of experience in GMP QA, a scientific background, and a strong knowledge of GMP regulations. #J-18808-Ljbffr
$122k - $150k
...Kailera Therapeutics, Inc. in Waltham, Massachusetts is looking for a Senior Specialist in GMP Quality Assurance. This role involves collaborating internally with various departments to ensure compliance and oversight. The ideal candidate should have over 6 years of experience...Senior$55 - $65 per hour
Vertex Pharmaceuticals in Boston is seeking a GMP Operational Quality Senior Specialist Contractor. The role involves providing quality oversight and compliance support for manufacturing operations, including leading investigations and supporting change control processes...SeniorFor contractors- ...Pharmaceuticals is seeking a Specialist in Quality Operations QA to provide on-site operational support... ...Cambridge manufacturing facility. This senior role involves managing QA review and approvals, ensuring compliance with GMP regulations, and leading investigations during...Senior
$123k - $166k
Wave Life Sciences is seeking a Senior Quality Assurance Specialist in Boston, MA. This position provides critical Quality Assurance oversight for... .... The ideal candidate must have an extensive background in GMP environments, experience with batch record review, and a bachelor...Senior$122k - $150k
...Senior Specialist, GMP Quality Assurance Waltham, Massachusetts At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit...SeniorLocal areaFlexible hours3 days per week$160k - $180k
...TScan is looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager supporting our internal GMP Cell therapy manufacturing. This position will be based in our cGMP Manufacturing site in Waltham, MA, and will directly support...SeniorWork at officeLocal areaFlexible hours$82.01k - $113.3k
A leading biotechnology company is seeking a Senior Laboratory Operations Associate in Watertown, MA. This role requires 3-5 years of hands-on experience... ...operations focusing on high-throughput chemistry and GMP. The ideal candidate will manage laboratory operations, handle...Senior$122k - $150k
Kailera Therapeutics is seeking an experienced professional to manage GMP documentation and ensure compliance within their Boston facility. The ideal candidate will have over 6 years in the FDA regulated pharmaceutical industry, demonstrating strong skills in documentation...SeniorFlexible hours- A leading biotech firm in Boston is looking for a Quality Assurance Specialist to oversee incoming raw materials and consumables. The ideal candidate... ...biotechnology environment. Responsibilities include reviewing GMP documentation, managing inventory, and ensuring compliance....Senior
- Healx is looking for a part-time Senior QA Auditor to lead quality assurance and compliance activities. You will work closely with the Global Head of Clinical Development, ensuring that processes meet GCP and GMP standards while collaborating with various teams in the company...SeniorPart timeFlexible hours
$115k - $140k
A medical diagnostics company in Bedford, MA is looking for a Senior Quality Systems Specialist I to oversee compliance with quality management systems. The role involves managing CAPA processes, facilitating audits, and supporting training programs. Ideal candidates will...SeniorRemote work- Vertex Pharmaceuticals is seeking a Senior Quality Specialist to provide QA support for manufacturing operations and analytical laboratory operations. This position involves... ...'s degree in a scientific field, experience in GMP oversight, and strong problem-solving skills....Senior
$55 - $65 per hour
...GMP Operational Quality Senior Specialist Contractor The GMP Operational Quality Senior Specialist Contractor supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of activities and supports...SeniorContract workTemporary workFor contractors- ...A leading healthcare institution in Boston seeks a Sr. Principal Scientist to oversee operations in a GMP lab, focusing on the production and quality control of radiopharmaceuticals. The ideal candidate will have extensive experience in aseptic operations, knowledge of...Senior
$163k - $200k
...professional ambitions. Reporting to the Senior Director, HR Operations & Total Rewards, the Associate... ...Operations is a strategic and hands‑on leader responsible for designing, scaling, and... ...Demonstrated ability to drive high quality and productivity in HR Operations, ensuring...SeniorTemporary workWork at officeLocal areaImmediate start3 days per week$160k - $175k
...Manager/Associate Director GMP Quality Reporting to : Director, GMP... ...responsible for day-to-day operational support ensuring compliance... ...quality operations, quality assurance, or GMP manufacturing within... ...Salary The salary range for the Senior Manager GMP Quality is...SeniorContract workRemote workWorldwideFlexible hours- ...Ardelyx is searching for a Quality Assurance Manager to oversee day-to-day quality operations at its Waltham, MA headquarters. The role involves significant responsibilities... ...degree in science, and a strong understanding of GMP regulations. This hybrid role offers competitive...Senior
$118.4k - $177.6k
Job Description The Quality Manager is an advanced technical resource... ...and application of quality assurance and compliance. The Quality... ...improvement activities. Conducts GMP document review, including... ...of GMP manufacturing operation including batch disposition....Work experience placementRemote workFlexible hours2 days per week$186k - $200k
...Kiniksa Pharmaceuticals is seeking an Assoc. Director, Quality to lead GMP technical transfer activities from development to commercial manufacturing, ensuring compliance with regulatory requirements and company standards. Located in Lexington, MA, the role requires a...Senior$82.01k - $113.3k
A leading biotechnology company is seeking a Senior Laboratory Operations Associate to manage high-volume laboratory operations. The ideal candidate... ...years of hands-on experience in high-hazard chemistry and GMP settings. Responsibilities include coordinating daily lab operations...Senior$70 - $80 per hour
...Job Description The Quality Manager is a technical resource in the principles and application of quality assurance, quality systems, and compliance. The Quality Manager... ...position reports directly to the GMP Operational Quality Senior Manager. Key Responsibilities Collaborate...Contract work- ...Senior Quality Assurance Operations Manager Join a fast-paced and international biotechnology business in Massachusetts. As the GMP QA Manager, you will play a key role in supporting quality operations... ...with other business leaders Innovation & Growth: Help build...Senior
- ...integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. We are seeking a Director, Quality Assurance, GMP focusing on clinical programs to join our team. This position will be an integral member of the Quality...Temporary workWork at officeRelocation package2 days per week
- ...Summary : The Sr. Quality Manager is an advanced technical resource... ...and application of quality assurance and compliance. The Sr.... ...systems Conducts GMP document review, including procedures... ...oversight of day-to-day operations Assists with workforce planning...Senior
- ...cohesive leadership team. Candidates should hold a BS in Pharmacy or PharmD, have active MA licensure, and 7+ years of leadership experience. Strong communication and analytical skills are essential to drive change and ensure high-quality patient outcomes. #J-18808-Ljbffr...Senior
- ...JobRx, Inc. is seeking an Associate Chief Pharmacy Officer (ACPO) to provide strategic leadership and operational oversight for clinical pharmacy at Boston Children's Hospital. The ACPO will advance clinical excellence and ensure compliance with all regulatory standards...Senior
$60k - $110k
Quality System Specialist/Senior Quality System Specialist Terrestrial (formerly known as Vaxess) is developing... ...to ensure compliance with applicable GMP/GLP standards. This position focuses... ...supporting quality system and GMP operations. Training and Compliance Support ● Provide...Senior- ...Dyne Therapeutics is seeking a Senior Lab Manager in Waltham, MA, to ensure smooth laboratory operations and compliance with EHS regulations. This role requires a dynamic individual with over 5 years in a BL2 lab environment, responsible for laboratory equipment maintenance...Senior
$75k - $125k
...A Higher Education Institution in Boston is seeking a Benefits Operations & Compliance Manager to oversee employee benefits programs. This role includes managing vendor relationships, ensuring compliance with regulations, and educating employees about benefits. Candidates...Senior$160k - $240k
...Rhythm Pharmaceuticals, Inc in Boston is seeking an experienced Regulatory Affairs Operations professional to manage regulatory operations activities and ensure compliance with internal and health authority standards. The ideal candidate will have over 8 years of experience...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior GMP Quality Assurance Operations Leader. Be the first to apply!
- senior performance engineer Lexington, MA
- senior manager diversity & inclusion Lexington, MA
- senior robotics software engineer Lexington, MA
- senior mainframe developer Lexington, MA
- senior cybersecurity engineer Lexington, MA
- senior manager m&a tax Lexington, MA
- senior accountant remote Lexington, MA
- senior level Lexington, MA
- senior scientific director Lexington, MA
- senior software engineer remote Lexington, MA


