Global Head of Biologics Quality & Compliance
Biogen, Inc.
Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team, ensuring quality across the biologics portfolio. This hybrid role can be based at the Research Triangle Park, NC or Cambridge, MA, and involves strategic, tactical, and operational leadership within GMP-aligned processes. The role requires extensive QA leadership, regulatory submission oversight, and cross-functional collaboration with CMC teams to drive quality excellence and continuous improvement. #J-18808-Ljbffr Biogen, Inc.
$184k - $253k
About This Role: As the Head of Global Product Quality for Biologics, you will lead a dynamic team responsible for overseeing all product quality aspects... .... This pivotal position not only guarantees quality compliance but also develops the capabilities of your direct...SuggestedTemporary workWork at officeLocal area- Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic team responsible for all product quality aspects within Biogen’s biologics portfolio. The role encompasses strategic, tactical, and operational management within the Product Development...Suggested
$216k - $324k
...seeking a Senior Director, Head of Quality Control to lead QC strategy... ...performance monitoring, and QC compliance across the external network.... ...degree in Biology, Cell Biology, Molecular Biology... ...HybridCompany InformationVertex is a global biotechnology company that invests...SuggestedFull timeContract workSummer workRemote workFlexible hours2 days per week$94.6k - $141.8k
...Associate Director, GMP Operational Quality Assurance is a Quality leader... ...resolve complex quality and compliance issues. The role provides... ...a key member of the Vertex Biologics and Devices Quality Team, influencing... ...setting, including global GMP manufacturing requirementsDemonstrated...SuggestedFull timeContract workSummer workRemote workFlexible hours2 days per week- ...comResponsibilities: This role is a member of the GVP QA team providing Quality oversight of the global post-marketing pharmacovigilance system, including... ...the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural...SuggestedWork experience placementRemote workWorldwide
$200k - $240k
...MATechnical Operations - Quality Control /Full-Time /On-siteScholar... ...critical unmet need.As a global leader in myostatin biology, a field focused on... ...control strategy, compendial compliance, specification lifecycle... ...scalability.Collaborate with the Head of Quality and cross-...Full timeContract work$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance Lead provides executive leadership and independent quality oversight of... ...growth, operational excellence, and long-term regulatory compliance.This role can be based in Cambridge, MA or Philadelphia,...Full timeTemporary workLocal areaRemote workFlexible hours- Take the lead in shaping global pharmacovigilance quality excellence, overseeing critical audit programmes, vendor quality, and regulatory compliance activities. R&D Partners is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide quality...
$10k
About This Role: As the Head of Quality for Device and Combination Products, you will lead the development and execution of the global quality strategy, focusing on devices and combination... .... Your leadership will drive compliance with regulatory and quality standards...Temporary workLocal area$210k - $290k
...The Senior Director, GMP Quality will build/support and maintain... ...to the Vice President, Head of Quality. Here's how you... ..., computerized systems compliance, and alignment with global regulatory expectations, cGMP... ...experience supporting biologics development, including GMP...Contract workFor contractorsShift work$116k - $174k
...will report to the Director of Quality and operate across... ...matrixed, outsourced model where compliance and inspection readiness are... ...partners to ensure compliance with global GMP requirements while supporting... ...'s Degree in Chemistry, Biology, Engineering or related field...Contract work$175k - $265k
...Description THE COMPANY PAX is a leading global cannabis brand on a mission to enhance... ...the world. SUMMARY As the Head of Product Quality, you will build, scale, and maintain... ...hardware innovation with strict medtech compliance, you will bridge ISO 13485 and ISO 900...Contract work$177k - $278.08k
...About the Role As the Director, Head of Quality Operations, you will play a pivotal leadership role in shaping the future of Clinical... ...effectiveness, operational excellence, and business performance across a global organization. In this highly visible role, you will lead...Minimum wageFull timeLocal areaWorldwide$244.8k - $367.2k
...Cell & Genetic Therapies (CGT) Quality vision, operating model, and... ...support portfolio growth and global commercialization.Serve as a... ...CGT programs to meet quality compliance requirements.Partner with functional... ...Cell & Gene therapy and/or Biologics.Broad and deep technical and...Full timeSummer workFlexible hours- Treeline in Watertown, MA seeks a Head of Quality Assurance to provide strategic and operational QA oversight across drug development... ..., Clinical Operations, and Supply Chain, and ensure compliance with global regulations to protect patient safety and data integrity....
$176.9k - $221.22k
Zenas is a clinical-stage global biopharmaceutical company committed... ...Analytical Development and Quality Control will lead the... ...analytical methodologies to support biologics product development from early... ...analytical readiness and compliance.Serve as a subject matter expert...$105k - $150k
...Manager, Product Quality Boston, MA Centessa Pharmaceuticals... ...product quality data to ensure compliance with specifications and... ...Maintain awareness of evolving global regulatory requirements impacting... ...'s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering...Full time$184.6k - $277k
...Manufacturing Process & Technical Quality provides Quality leadership... ...Quality Management System, global regulatory expectations, and... ...delivery of commitments.• Ensure compliance with the Vertex Quality... ...in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.).· In depth...Full timeSummer workRemote workFlexible hours2 days per week- ...Vertex is seeking a CMC Quality Compliance Director to lead inspection readiness and compliance across GMP sites, including external CMOs and internal manufacturing. You will drive risk-based governance and strategic improvements to quality systems. The role requires...
- Sarepta Therapeutics is seeking a Director, Corporate Quality to lead GCP/GLP QA across Clinical Development and Real-World Evidence. You will ensure FDA/ICH compliance and partner with Clinical, Pharmacovigilance, and Research teams to uphold patient safety and scientific...
$216k - $324k
...Vertex Pharmaceuticals seeks a Senior Director to lead quality control strategy and external laboratory oversight for Type 1 Diabetes... ...and analytical readiness Requirements ~ Advanced degree in Biology, Cell Biology, Molecular Biology, Biochemistry, Analytical Chemistry...Contract work$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence. Leading the charge in designing, implementing, and sustaining the enterprise Quality Risk Management (QRM) capabilities...Full timeTemporary workLocal area- Proclinical seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality oversight of global PV systems from Cambridge, MA... ...of Global PV Quality Assurance and focuses on GVP compliance, audit programs, inspection readiness, and cross-functional...Remote job
$185k - $235k
...is seeking a Senior Director Quality GCP to provide strategic oversight... .... Develop a risk-based GCP compliance program. Support teams in the... ...in Chemistry, Pharmacy, Biology or a related life science, or... ...supporting GCP compliance with US and global regulations (FDA, EMA, ICH,...$217.6k - $326.4k
...Summary:The Sr. Director, GCP Operational Quality will advance and provide strategic... ...proactive and sustainable clinical quality, and compliance for assigned programs. This individual... ...with business stakeholders across Global Clinical Operations, Medical Affairs, Regulatory...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week$240k - $285k
...Facebook.Role Summary:The Senior Director, Quality Control leads the strategy and... ...lifecycle management. This role ensures global GMP compliance, inspection readiness, and robust analytical... ...New Drug applications, Biologics License Applications, and Marketing Authorization...Contract workLocal area- ...Head of Quality Operations About the Company Innovative audio data research company Industry Computer Software Type Privately Held, VC-backed Founded 2024 Employees 11-50 Funding $11-$25 million About the Role The Company is seeking...
$137.8k - $206.8k
...Senior Manager, Clinical Study Quality Lead provides study-level quality... ...ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and... ...programs for drugs and biologics.Required Knowledge/Skills:Strong...Full timeSummer workRemote workFlexible hours2 days per week- Alnylam is seeking a Senior PV QA Auditor to provide quality oversight for the global postmarketing PV system. The role focuses on auditing, CAPA... ...collaborating with cross-functional PV teams to ensure regulatory compliance and continuous improvement. #J-18808-Ljbffr Lancesoft
$185.5k - $344.5k
...MAInternal: DirectorLI#-HybridThis role oversees the Study Quality and Compliance team within the Toxicology line function of Preclinical Safety... ...be transferredEssential Requirements: Advanced degree in biological-related sciences with at least 10 years of relevant...Full time
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