Associate Director, External Supplier QA GMP

Merck & Co.; Basking Ridge (NJ); On-site; USD 153,600 - 230,400; Full time

Job summary

Merck & Co. seeks a Quality Assurance professional to oversee contract manufacturing organizations, ensuring compliance with FDA regulations and internal standards. Your role will focus on quality management systems, process validation, and complaint investigation. Ideal candidates have extensive pharmaceutical experience and knowledge in drug manufacturing and QA compliance.

This position is poised for impact in a collaborative environment, supporting global operations with potential travel requirements up to 30%. A Bachelor's degree in a scientific field is essential, while a Master's is preferred.

Qualifications

• 7+ years in pharmaceutical and/or biological operations, including drug manufacturing and QA.
• 4+ years experience with multinational drug regulators.
• Solid understanding of cGMP and continuous process improvement.

Responsibilities

• Lead Quality Management System at CMOs ensuring compliance.
• Support operational activities including manufacturing, packaging, and QC.
• Participate in cross-functional teams to influence operations.

Skills

Drug manufacturing knowledge

QA compliance

Experience with contract manufacturing organizations

Aseptic/Sterile Manufacturing

Risk assessment strategies

Education

Bachelor’s Degree in a scientific discipline

Master’s Degree or advanced degree

Job description

Job Summary

Accountable to lead, manage and ensure that all Contract Manufacturing, Testing and Warehousing organizations contracted by or on behalf of Daiichi Sankyo that provide services through the supply of commercial and investigational drug product are constantly assessed to comply with FDA premises and regulation, applicable GMP guidelines and internal DS policies, procedures or standards. The incumbent is responsible for identifying QA risks at CMOs and supporting recommended courses of risk treatment and resolution, ensuring continuous improvement in the management of CMO risks. Interacts with DS affiliates and Headquarters to support routine and unusual issues related to Global Products.

Responsibilities

Quality Management System (QMS): Ensures and supports that a robust QMS is in place at CMOs with respect to the facility, equipment & laboratory instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.

Drug Product Management: Supports technically the operational activities which include API and drug product manufacturing, packaging and labelling operations, QC testing and release, and distribution for biologics and small‑molecule products manufactured at CMOs and ensures the validation requirements for all global markets are also met.

Cross‑Functional Team Participation: Works with Quality Leaders in each operating site to influence and affect necessary operations managed through the leadership teams and partners closely with other Subject Matter Experts across all Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA‑GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations.

Process Validation and Product Technical Transfer: Responsible for review and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that may require DS support; ensures compliance with applicable DSI and/or DS relevant procedures, standards and instructions affecting CMO activities. Supports oversight and QA support for product and process technology for acquired or transferred product into and out of CMO organizations.

Deviation and Complaint Investigation Program: Provides support to the investigation of deviations and complaints to ensure a timely resolution and protective solution to avoid any risk to the quality and safety of commercial and investigational drug products supplied through DSI and DS affiliates.

Qualifications

• Education Qualifications: Bachelor’s Degree in a scientific discipline required or Master’s Degree or other advanced degree preferred.
• Experience Qualifications: 7 or more years in pharmaceutical and/or biological operations including first‑hand knowledge of drug manufacturing, packaging, QA, compliance and audit; experience with bio manufacturing and technical transfer required.
• 4 or more years direct experience dealing with multinational drug regulators is required; previous management experience would be preferred.
• Solid understanding of quality management and continuous process improvement principles including global cGMP requirements is required.
• Experience with Aseptic/Sterile Manufacturing and/or in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications is strongly preferred.
• Experience dealing with contract manufacturing organizations is required.

Travel Requirements

Ability to travel up to 30% of the time.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

USD$153,600.00 - USD$230,400.00