Director, Contract Testing Laboratories Quality Oversight

Merck; West Point (PA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Merck is seeking a Director of Contract Testing Laboratories Quality Oversight to lead the external quality organization responsible for CTLs and cell banking oversight globally. The role drives governance, risk management, and continuous improvement across GLP/GMP testing, ensuring patient safety and regulatory alignment.

The incumbent will build and mentor a high-performing QA team, implement performance metrics, and collaborate with internal and external partners to remediate gaps and

Qualifikationen

• Minimum 10 years of experience in Quality Systems, QA, and/or QC within pharmaceutical manufacturing under GMP and health authority requirements.
• Proven track record managing complex quality investigations, risk assessments and data-driven decisions.
• Strong regulatory compliance background with experience supporting regulatory inspections and health authority interactions.

Aufgaben

• Leads strategy, budget oversight and performance management of CTL quality oversight organization.
• Establishes risk-based quality oversight model for contract testing laboratories and cell banking.
• Provides operational leadership to labs for drug substance, drug product and finished product testing.
• Ensures GLP/GMP compliance and regulatory expectations are met across testing, storage and retention.
• Oversees investigations, OOS, deviations, and remediation to protect launch and supply continuity.
• Leads quality assessments for prospective labs and new methods; defines governance routines and metrics.

Kenntnisse

Change Management

Data Integrity

Quality Assurance

Regulatory Compliance

Leadership

Quality Auditing

Ausbildung

Bachelor's degree in a scientific discipline

Jobbeschreibung

Director, Contract Testing Laboratories Quality Oversight

The Director, Contract Testing Laboratories (CTL) Quality Oversight is a critical leadership role within our external Quality organization. The incumbent is accountable 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.

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.

Required Skills

• Change Management, Change Management, Coaching, Data Integrity, Decision Making, Good Lab Practices, Interpersonal Relationships, Legal Compliance, Manufacturing Quality Control, Operational Efficiency, Operational Quality, Organizational Leadership, People Leadership, Performance Improvements, Performance Metrics, Performance Plans, Product Testing, Quality Assurance Processes, Quality Assurance Systems, Quality Auditing, Quality Control Management, Quality Control Systems, Quality Management, Quality Management Standards, Quality Measurements {+ 10 more}

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, colo