Associate Director, GDP Operational Quality Specialist
1 day ago
The Associate Director, GDP Operational Quality role is responsible for ensuring that medicines are distributed in the US in compliance with GDP and GMP requirements. This position will work with the GDP Operational QA Management team to maintain the quality of products and ensure compliance with regulatory requirements.
Key Responsibilities- Manage the day-to-day quality oversight of the Third Party Logistics provider
- Provide support for key stakeholders within Vertex
- Review and maintain Quality Agreements
- Analyze and resolve compliance and customer issues
- Escalate issues as necessary
- Remain up-to-date on GDP and logistics developments and emerging regulations
- Accountable for New Product Launch activities within the US
- Collaborate with internal stakeholders to maintain the Quality Management System
- Ensure distribution licenses accurately reflect the current organization
- Support recalls, mock recalls, and on-market activities
- Bachelor's degree in a scientific or allied health field and relevant GDP & GMP work experience
- 5+ years' experience serving in a Quality role
- Clear understanding of GDP and GMP requirements
- Influencing skills in areas with no direct reporting authority
- Strong interpersonal and communication skills
- Auditing skills, with appropriate qualifications in auditing an advantage
This Hybrid-Eligible role offers the flexibility to work remotely up to two days per week or work five days per week on-site with ad hoc flexibility.
About VertexVertex is a global biotechnology company that invests in scientific innovation. We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
-
Director, GMP Operational Quality
19 hours ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob DescriptionGeneral Position Summary:The GMP Quality Operations Director plays a key role in ensuring the quality of oral solid dosage form products. This position is responsible for providing quality oversight and support to the Vertex Manufacturing Center (VMC) Facility operation in various areas, including manufacturing operations, analytical...
-
Director of Quality Operations
1 day ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob DescriptionThe GMP Quality Operations Director plays a pivotal role in ensuring the quality and compliance of Vertex's oral solid dosage form manufacturing operations. This position requires a strong leader who can oversee multiple department activities, provide quality oversight, and drive the development and implementation of quality initiatives.Key...
-
Boston, Massachusetts, United States Integrated Resources Full timeJob Title: Associate Director Data OperationsWe are seeking a highly skilled Associate Director Data Operations to join our team at Integrated Resources. As a key member of our Digital Health Technology team, you will play a critical role in supporting the operational initiation, vendor and digital data monitoring, and data cleaning process efforts within...
-
Manufacturing Operations Specialist
3 weeks ago
Boston, Massachusetts, United States Software Galaxy Systems, LLC Full timeJob SummaryWe are seeking a highly skilled and detail-oriented Manufacturing Operations Specialist to join our team at Software Galaxy Systems, LLC. As a key member of our production team, you will be responsible for executing manufacturing operations on site, maintaining a clean and orderly work environment, and ensuring compliance with cGMP/ISO systems.Key...
-
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob SummaryVertex Pharmaceuticals is seeking an experienced Associate Director to lead the Quality Operations team in our Cell and Gene Manufacturing department. The successful candidate will be responsible for ensuring the quality and compliance of our manufacturing processes, as well as developing and implementing continuous improvement initiatives.Key...
-
Boston, Massachusetts, United States Ironwood Pharmaceuticals Full timeJob Title: Associate Director, Sales OperationsIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with...
-
Podiatrist - Medical Director Services PC
4 weeks ago
Boston, Massachusetts, United States Medical Director Services PC Full timeJob Summary:Medical Director Services PC is seeking an experienced Podiatrist to provide professional and medical podiatric services to patients with conditions affecting the foot, ankle, and related structures in skilled nursing facilities throughout Massachusetts. Inquire about availability in other states as well.Key Responsibilities:Provide essential...
-
Associate Director, Operations
5 days ago
Boston, Massachusetts, United States Northeastern University Full timeAbout the OpportunityThe Associate Director, Loans & Operations will oversee the management of operations for 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.Key...
-
Podiatrist Specialist
1 week ago
Boston, Massachusetts, United States Medical Director Services PC Full timePodiatrist Job OpportunityMedical Director Services PC is seeking an experienced Podiatrist to provide medical services to patients with conditions affecting the foot, ankle, and related structures in skilled nursing facilities throughout Massachusetts. Inquire about availability in other states as well.Job Summary:Provide professional and medical podiatric...
-
Podiatrist Specialist
2 weeks ago
Boston, Massachusetts, United States Medical Director Services PC Full timePodiatrist Job OpportunityMedical Director Services PC is seeking an experienced Podiatrist to provide medical services to patients with conditions affecting the foot, ankle, and related structures in skilled nursing facilities throughout Massachusetts. Inquire about availability in other states as well.Job Summary:Provide professional and medical podiatric...
-
Boston, Massachusetts, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking an experienced Associate Director, Clinical Quality Compliance to join our team. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and...
-
Associate Director of Operations
23 hours ago
Boston, Massachusetts, United States Northeastern University Full timeAbout the OpportunityThe Associate Director, Loans & Operations will oversee and manage the operations for the full scope of university disbursement processes and all educational loan processing within Student Financial Services.Disbursement processing includes, but is not limited to, PowerFAIDS disbursement setup, scheduling, and maintenance; scheduling and...
-
Associate Director of Development Operations
4 days ago
Boston, Massachusetts, United States Massachusetts General Hospital(MGH) Full timeJob Title: Associate Director of Development, OperationsThe Associate Director of Development, Operations plays a critical role in managing key operational functions for the Development Office at Massachusetts General Hospital. This position requires a collaborative and service-oriented approach to identify and implement innovative, data-driven solutions to...
-
Associate Creative Director, Copy Specialist
1 week ago
Boston, Massachusetts, United States Mullen Full timeJob Title: Associate Creative Director, CopyWe are seeking a highly skilled Associate Creative Director, Copy to join our team at MullenLowe. As a key member of our creative department, you will be responsible for developing and executing high-quality, creative advertising materials that meet and exceed client expectations.Key Responsibilities:Develop 360...
-
Associate Director/Director, Laboratory Operations
17 hours ago
Boston, Massachusetts, United States Monte Rosa Therapeutics Full timeJob Title: Associate Director/Director, Laboratory OperationsMonte Rosa Therapeutics is seeking an experienced operations professional to lead and coach the office and lab operations teams in Boston and Basel. The successful candidate will demonstrate effective collaboration and partnership across all levels in the company and leverage their experience in...
-
Associate Director, Supply Chain Operations
11 hours ago
Boston, Massachusetts, United States Chewy Full timeJob Title: Associate Director, Instock ManagementChewy is seeking a highly motivated and results-driven Associate Director, Instock Management, to join our Chewy Vet Care team. This role is critical for leading the development and management of our supply chain operations, ensuring efficiency and accuracy across our network.Key Responsibilities:Lead a team...
-
Associate Director of Financial Aid Operations
2 weeks ago
Boston, Massachusetts, United States InsideHigherEd Full timeAbout the RoleBoston University Student Financial Services is seeking an Associate Director of Outreach to join our team. This role will work closely with the Associate Director of Operations and the Director of Student Financial Services to administer a holistic financial aid program that supports the recruitment and retention efforts of the Medical...
-
Boston, Massachusetts, United States Daiichi Sankyo Full timeJob Title: Associate Director Field ReimbursementJoin Daiichi Sankyo, a global pharmaceutical innovator, in a critical role that drives patient access to our oncology products. As an Associate Director Field Reimbursement, you will serve as a field-based product access specialist, providing reimbursement support to healthcare professionals and facilitating...
-
Boston, Massachusetts, United States Monte Rosa Therapeutics Full timeJob Title: Associate Director/Director, LaboratoryMonte Rosa Therapeutics is seeking an experienced operations professional to lead and coach the office and lab operations teams in Boston and Basel. The ideal candidate will have a strong background in research and development strategies and processes, laboratory operations, lab regulatory requirements,...
-
Manufacturing Specialist
7 days ago
Boston, Massachusetts, United States DPS Group Global Full timeJob Title: Manufacturing SpecialistArcadis DPS Group is seeking a highly skilled Manufacturing Specialist to join our team. As a key member of our production team, you will be responsible for ensuring the efficient and effective operation of our manufacturing processes.Key Responsibilities:Operate and maintain manufacturing equipment, including cell culture...