Director, Contract Testing Laboratories Quality Oversight
MSD
Summary
The Director, Contract Testing Laboratories (CTL) Quality Oversight is a critical leadership role within our external Quality organization. The incumbent is accountable for implementing Divisional and Company policies, procedures, and guidelines, and for Quality Assurance responsibilities for our company's contracted testing services globally. This role ensures that all product modalities (drug substance, drug product, finished product) tested at CTLs are analyzed and that cell banking manufacture and storage is in accordance with Company standards and all applicable regulatory requirements, meeting both internal and external customer demands and protecting patient safety.
Job description
Primary Responsibilities
- Leads the strategy, organisational design, budget oversight and performance management of the contract testing laboratories and cell bank quality oversight organisation.
- Establishes and maintains a risk-based quality oversight model for our company's contract testing laboratories.
- Establishes and maintains a risk-based quality oversight model for cell banking.
- Provides operational leadership to the contract testing laboratories accountable for drug substance, drug product and finished product testing.
- Provides Quality oversight of the contract testing laboratories to ensure products are tested, stored and retained in accordance with regulatory expectations, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and our company's requirements.
- Provides Quality oversight to resolve quality issues, out-of-specification (OOS) investigations, and deviations that could impact launch or supply continuity representing all using sites and functions.
- Provides Quality oversight for analytical technology transfer.
- Defines clear performance expectations, metrics and governance routines to monitor and improve quality and operational performance.
- Lead Quality assessments for prospective contract test laboratories or new method citing and ensure gaps are remediated appropriately.
- Establish and maintain Quality agreements to protect our company's quality and compliance requirements.
- Direct, mentor, and develop a high-performing team of quality assurance professionals dedicated to external testing laboratory oversight.
- Promote a culture of accountability, collaboration, operational excellence, and proactive problem-solving across the internal organisation and external testing network.
Education
Bachelor's degree in a scientific discipline required.
Required Experience and Skills
- Minimum of ten (10) years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements.
- Proven track record managing complex quality investigations, assessing risk, and making timely, data-driven decisions.
- Strong compliance background with experience supporting regulatory inspections and health authority interactions.
- Demonstrated success leading and developing teams.
- Ability to travel approximately 30% of the time, including occasional short-notice travel.
Preferred Technical/Functional Skills
- Advanced degree in a relevant scientific or technical field.
- Experience leading external partners across biologics or vaccines.
- Prior leadership of a multinational organization with direct accountability for partner performance, compliance, and supply support.
- Strong knowledge of quality governance models, supplier oversight, and risk-based quality management systems.
- Experience partnering with leadership at external partners to influence performance, strengthen quality systems, and accelerate remediation.
- Broader exposure to operations, engineering, supply chain, and commercial functions.
- Experience leading transformation, standardization, or continuous improvement initiatives.
Requirements
- Bachelor's degree in a scientific discipline required
- Minimum of ten (10) years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements
- Proven track record managing complex quality investigations, assessing risk, and making timely, data-driven decisions
- Strong compliance background with experience supporting regulatory inspections and health authority interactions
- Demonstrated success leading and developing teams
- Ability to travel approximately 30% of the time, including occasional short-notice travel
Benefits
- Medical, Dental & Vision
- Other Insurance Benefits
- 401(k)
- Retirement Benefits
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Leave
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.