Senior Manager/Associate Director, Quality Operations
4 weeks ago
We are seeking a highly experienced Senior Manager/Associate Director, Quality Operations to provide quality oversight for our biologics commercial programs. The ideal candidate will have a strong background in GMP quality and experience managing complex business relationships with QPs/EU business partners.
Key Responsibilities- Ensure CMO compliance with applicable cGMP regulations, batch records, product registrations, quality agreements, and data integrity standards.
- Support QA batch record reviews and lot dispositions of commercial drug substance and drug product per established procedures for internal and business partner use.
- Lead quality aspects and provide support to our business partners on QA-related investigations, change controls, lot dispositions, and regulatory requests.
- Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).
- Review and approve controlled documents, including commercial manufacturing and packaging master batch records, protocols, and final reports.
- Work with our Quality Systems and CMC teams to ensure quality and technical documentation is delivered to the internal archiving system.
- Provide guidance, advice, and support for GMP quality and compliance matters.
- Represent Quality as PIP at CMO's as necessary to support production operations.
- Demonstrate a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
- University degree in life sciences or related fields.
- 5+ years' experience in GMP Quality in biopharma/biologics/pharmaceutical industry.
- Experience working directly with contract manufacturing organizations (CMOs) is required.
- Direct interaction with FDA, EMA, or other regulatory agencies during regulatory inspections and qualified persons (QPs) is required.
- Experience in biologics is required.
- Experience in sterile drug product manufacturing is preferred.
- Thorough knowledge of cGMP regulations.
- Experience supporting commercial and lifecycle management.
- Experience in oversight of contract manufacturing.
- Proficiency in electronic QMS Software such as Veeva, Trackwise, etc.
We offer a competitive salary, annual bonus, equity, 401(k) program, and remote work options. If you are a motivated and experienced professional looking for a new challenge, please apply now by clicking the "Apply Now" button.
-
Director of Quality Operations
4 weeks ago
Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full timeJob SummaryVertex Pharmaceuticals is seeking a highly experienced and skilled Director of Quality Operations to lead our Quality Operations team in ensuring the highest standards of quality in our oral solid dosage form manufacturing processes. As a key member of our Quality Leadership Team, you will be responsible for developing and implementing quality...
-
Director of Quality Operations
4 weeks ago
Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full timeJob SummaryThe Director of Quality Operations will serve as a key leader in the areas of process validation, equipment validation, and quality initiatives in support of Vertex Manufacturing Center (VMC) Facility operations.Key ResponsibilitiesLead the Quality Operations group in providing quality oversight and support to manufacturing operations, analytical...
-
Associate Director, Quality Operations
4 weeks ago
Étreux, Hauts-de-France, United States Jobot Full timeJob SummaryWe are seeking an experienced Associate Director of Quality Operations to provide laboratory QA support for our biologics commercial and clinical development programs. The successful candidate will work closely with our contract development and manufacturing organizations to ensure compliance with established procedures, cGMP, regulatory...
-
Associate Director of Development Operations
4 weeks ago
Étreux, Hauts-de-France, United States Massachusetts General Hospital(MGH) Full timeAbout the RoleThe Associate Director of Development, Operations plays a critical role in managing key operational functions for the Development Office at Massachusetts General Hospital. Reporting to the Senior Director of Operations, this individual will collaborate with a team of nine colleagues to drive innovation, enhance productivity, and improve...
-
Senior Director of Quality Assurance
4 weeks ago
Étreux, Hauts-de-France, United States AVEO Oncology Full timeJob Summary:The Senior Director of Quality Assurance at AVEO Oncology is responsible for leading quality operations and strategic leadership, ensuring compliance with US, EU, and other applicable regional regulations. This role requires a high level of expertise in the industry, with a focus on quality strategic leadership and compliance activities related...
-
Senior Director, Strategy and Operations
4 weeks ago
Étreux, Hauts-de-France, United States Clear Way Health Full timeClearway Health: A Leader in Specialty Pharmacy SolutionsClearway Health is a high-growth, for-profit subsidiary of Boston Medical Center (BMC) Health System. We partner with hospitals and health systems to build or strengthen their own specialty pharmacy programs, improving access to care and providing personalized support to vulnerable patients, families,...
-
Director of Operations
4 weeks ago
Étreux, Hauts-de-France, United States The LEGO Group Full timeJob DescriptionAt The LEGO Group, we are passionate about inspiring creativity and learning through play. We are seeking a highly skilled Director of Operations to join our team.This role is critical in scaling senior leadership within Brand Marketing Insights and Partnerships. With the significant recent growth of the brand and business, and the...
-
Senior Director, Pharmacovigilance Operations
3 weeks ago
Étreux, Hauts-de-France, United States Takeda Pharmaceuticals Full timeAbout the RoleAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Senior Director, Pharmacovigilance Operations, you will provide leadership and oversight to Global and Regional PV Operational Teams to ensure adverse event information is processed according to...
-
IT Director, US Operations
4 weeks ago
Étreux, Hauts-de-France, United States Galderma S.A. Full timeJob Title: Associate Director, US ITGalderma is a leading dermatology company with a presence in over 90 countries. We are seeking a highly experienced IT Associate Director to lead our IT strategy and operations in the US region.Key Responsibilities:Lead the development and implementation of IT strategy in the US region, aligning with the company's overall...
-
Senior Director, Clinical Data Management Leader
4 weeks ago
Étreux, Hauts-de-France, United States Takeda Pharmaceutical Company Ltd Full timeSenior Director, Clinical Data ManagementAre you a seasoned leader with a passion for clinical data management? Do you have a proven track record of driving operational excellence and innovation in a fast-paced environment? If so, we want to hear from you!About the RoleWe are seeking a highly experienced Senior Director, Clinical Data Management to join our...
-
Associate Director of Development Operations
4 weeks ago
Étreux, Hauts-de-France, United States Massachusetts General Hospital Full timeAbout the RoleThe Associate Director of Development, Operations is a key member of the Development Office at Massachusetts General Hospital, responsible for managing key operational functions to support the department's mission. With a collaborative and service-oriented approach, this role identifies and implements innovative solutions to meet operational...
-
Associate Director, Quality Assurance
4 weeks ago
Étreux, Hauts-de-France, United States PepGen Full timeAbout the RoleWe are seeking a highly experienced Associate Director, Quality Control to join our team at PepGen. As a key member of our Quality Control department, you will be responsible for leading and managing the QC activities of our pipeline, ensuring compliance with regulatory requirements and company standards.Key ResponsibilitiesLead and manage...
-
Operational Excellence Associate Director
4 weeks ago
Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full timeJob Title: Operational Excellence Associate DirectorJob Summary:Vertex Pharmaceuticals is seeking an experienced Operational Excellence Associate Director to join our Project Management and Strategy Office (PMSO) team. The successful candidate will be responsible for identifying and leading process improvement project initiatives to increase organizational...
-
Senior IP Operations Manager
3 weeks ago
Étreux, Hauts-de-France, United States Troutman Pepper Hamilton Sanders LLP Full timeWe are seeking a highly skilled and experienced Senior IP Operations Manager to join our team at Troutman Pepper Hamilton Sanders LLP.The ideal candidate will have a strong background in intellectual property operations, with a proven track record of successfully managing workflow, developing relationships with internal and external clients, and delivering...
-
Senior Director of Finance
3 weeks ago
Étreux, Hauts-de-France, United States Boston Medical Center Full timeJob Title: Senior Director of FinanceJob Summary: Boston Medical Center is seeking an experienced Senior Director of Finance to lead the financial operations of BMCAP. The ideal candidate will have a strong background in financial management, with experience in healthcare finance.Key Responsibilities:Develop and implement financial plans and budgetsOversee...
-
Senior Program Director
4 weeks ago
Étreux, Hauts-de-France, United States Vinfen Full timeAbout the RoleVinfen is seeking a highly skilled and experienced Senior Program Director to oversee the clinical, financial, and administrative operations of our programs. As a key member of our leadership team, you will be responsible for ensuring the delivery of high-quality services to individuals with mental health conditions, intellectual and...
-
Operations Director
4 weeks ago
Étreux, Hauts-de-France, United States Scion Staffing Full timeJob Title: Director of OperationsAbout the Role:Scion Nonprofit Staffing is seeking a highly skilled Director of Operations to join our team. As a key member of our organization, you will be responsible for managing all back-office operations, including people operations, systems planning, internal reporting, and administration.Key Responsibilities:Manage...
-
Associate Director Operations
4 weeks ago
Étreux, Hauts-de-France, United States Northeastern University Full timeAbout the OpportunityThe Associate Director, Loans & Operations will oversee and manage the full spectrum of university disbursement processes and educational loan processing within Student Financial Services. This includes disbursement setup, scheduling, and maintenance, as well as exception reporting, staff communications, and training. The role will also...
-
Director of Quality and Safety
4 weeks ago
Étreux, Hauts-de-France, United States AAGL Full timeJob SummaryThe Director of Quality and Safety will lead quality and safety efforts in both inpatient and ambulatory settings for the Department of Obstetrics and Gynecology at Boston Medical Center. This role will direct quality and safety initiatives, collaborate with department leaders, and oversee the quality and safety project team.Key...
-
Associate Director of Operations and Loans
4 weeks ago
Étreux, Hauts-de-France, United States College of Charleston Full timeAbout the OpportunityThe Associate Director, Loans & Operations will oversee and manage the full scope of university disbursement processes and educational loan processing within Student Financial Services.Key responsibilities include:Directing and managing operations for disbursement processing, including PowerFAIDS setup, scheduling, and maintenance, as...