AVP, External Quality

Job Description

The Head of External Manufacturing Quality – Large Molecule leads our Manufacturing Division's global External Manufacturing Quality organization for biologics and vaccines.

This leader directs a multinational team of approximately 100 professionals and establishes the quality strategy, governance, and oversight model for products manufactured, tested, packaged, released, stored, and distributed through our company's external manufacturing network.

The role ensures compliance with our company's requirements, applicable regulatory expectations, and global GMP standards while enabling reliable supply, supporting timely product launches, and strengthening the execution of technology transfers across approximately 30 external manufacturing sites spanning cell banking, drug substance, and drug product operations.

This role sets the direction for a global External Manufacturing Quality organization that protects product quality, patient safety, and regulatory compliance while enabling business continuity and supply reliability. The position serves as a senior quality leader across our company's biologics and vaccines networks, driving consistent standards, strong partner oversight, and effective governance that support launch readiness, lifecycle execution, and operational excellence across the external manufacturing network. The role reports to the Vice President of Quality, Global Biologics.

Primary Responsibilities:

• Lead the strategy, organizational design, budget oversight, and performance management for a global External Manufacturing Quality team of approximately 100 professionals.

• Establish and maintain a risk-based quality oversight framework for approximately 30 external manufacturing sites supporting cell banking, drug substance, drug product, packaging, testing, release, storage, and distribution.

• Direct quality oversight of external manufacturing partners to ensure products are manufactured, tested, packaged, and released in accordance with our company's requirements and global regulatory expectations.

• Drive timely product release, or coordination of release, for external supplier-manufactured materials to support supply continuity and customer demand.

• Lead major External Manufacturing Quality investigations, including fact finding, root cause assessment, regulatory notifications, and recall coordination when required.

• Provide quality leadership for technology transfers, product launches, pre-approval inspections, and other critical supply and regulatory milestones.

• Strengthen partner readiness by providing strategic quality support, technical guidance, and direct engagement with external partner leadership teams.

• Review audit and inspection outcomes for external manufacturers and ensure effective corrective and preventive actions are defined, implemented, and sustained.

• Oversee complaint review and quality issue escalation processes for products manufactured through the external network.

• Define clear performance expectations, metrics, and governance routines to monitor and improve quality and operational performance across external partners.

• Chair periodic quality performance reviews with external manufacturing partners to drive accountability, transparency, and continuous improvement.

• Lead due diligence assessments for prospective external partners and ensure identified gaps are addressed through appropriate remediation and oversight.

• Establish and maintain Quality Agreements and provide expert consultation on commercial agreements as needed to protect our company's quality and compliance requirements.

• Build effective quality systems at partner sites through calibrated oversight, continuous improvement initiatives, and targeted support aligned to risk and performance.

• Establish and chair the External Manufacturing Quality Council and communicate key quality, compliance, and business risks to senior leadership forums.

• Serve as a member of the Biologics Quality Leadership Team and External Manufacturing Leadership Team, with dotted-line partnership to the Vaccines Quality Leadership Team and other relevant governance bodies.

• Promote a culture of accountability, collaboration, operational excellence, and proactive problem-solving across the internal organization and external partner network.

Education:

• Bachelor’s degree in a scientific discipline required

• Advanced degree preferred

Required Experience and Skills:

• Minimum of 10 years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements.

• Demonstrated experience leading quality oversight of third-party manufacturers in a regulated environment, ideally within FDA/cGMP and global regulatory settings.

• 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.

• Significant experience across quality operations, including quality laboratories, batch release, quality assurance, and quality systems.

• Demonstrated success leading and developing large, global, matrixed teams.

• Experience with biologics and vaccines manufacturing across multiple nodes, including drug substance, drug product, packaging, and laboratories.

• Experience supporting technology transfers, product launches, pre-approval inspections, and facility start-up activities.

• 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 global external manufacturing quality networks across both biologics and vaccines.

• Prior leadership of a large multinational quality 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 senior leadership at external manufacturing sites to influence performance, strengthen quality systems, and accelerate remediation.

• Broader exposure to operations, engineering, supply chain, and commercial functions.

• Deep familiarity with global regulatory agencies and inspection readiness, including FDA, EMA, TGA, and ANVISA.

• Experience leading quality transformation, standardization, or continuous improvement initiatives across a global external manufacturing network.

Enterprise Leadership Skills for a Multi-Team Leader:

Strategic Planning

• Develops and implements strategic plans that align with long-term organizational goals by obtaining relevant information and identifying key issues and relationships.

• Commits to actionable strategies based on thorough analysis of alternatives, logical assumptions, facts, and available resources while considering constraints and organizational values.

• Facilitates collaboration across multiple teams to ensure alignment and effective execution of strategic initiatives.

Networking & Partnerships

• Cultivates and maintains strategic relationships with key stakeholders and potential partners both inside and outside the organization, including customers, cross-functional partners, external vendors, and alliance partners.

• Initiates collaboration with individuals who can provide valuable information, insights, expertise, and influence to enhance understanding of business issues and drive achievement of organizational goals.

• Leverages networks to identify opportunities for innovation and collaboration that support business objectives.

Influence

• Develops and implements effective influence strategies to gain commitment to ideas and initiatives from key stakeholders.

• Persuasively communicates and advocates for actions that align with shared interests and advance business goals.

• Cultivates relationships with stakeholders to enhance credibility and foster collaboration, ensuring that broad perspectives are integrated into decision-making processes.

Execution Excellence

• Translates strategic priorities into actionable operational plans while ensuring compliance with organizational standards.

• Establishes and upholds high standards for performance, accountability, and communication across teams.

• Develops and optimizes resource capabilities and internal processes to support the execution of strategic priorities.

• Implements ongoing measurement systems to track progress and ensure that strategic initiatives yield measurable and sustainable results.

Change Catalyst

• Drives organizational and cultural change initiatives to align with and achieve strategic priorities.

• Catalyzes innovative approaches to enhance performance by transforming organizational culture, systems, and products/services.

• Supports team members and stakeholders in overcoming resistance to change through effective communication, engagement strategies, and training.

• Fosters a culture of adaptability and resilience, encouraging a proactive approach to change among all team members.

Motivation and Inspiration

• Inspires and motivates team members to achieve higher levels of performance in alignment with the organization’s Purpose and Strategic Framework.

• Communicates a clear vision and sets an example of commitment and excellence, encouraging others to embrace organizational goals.

• Recognizes and celebrates individual and team achievements, fostering a positive and supportive work environment.

• Provides ongoing feedback and development opportunities to help individuals realize their full potential and contribute effectively to the organization’s success.

Required Skills:

Auditing, Auditing, cGMP Compliance, Commercial Agreements, Cross-Cultural Awareness, Customer-Focused, Detail-Oriented, Ethical Compliance, GMP Compliance, Interpersonal Relationships, Operational Excellence, Organizational Design, Patient Safety, People Leadership, Pharmaceutical Manufacturing, Quality Assurance (QA), Quality Improvement Programs, Quality Investigations, Quality Management System Improvement, Regulatory Compliance, Results-Oriented, Risk Assessments, Strategic Initiative, Supplier Quality Management, Supplier Relationship Management {+ 1 more}

Preferred Skills:

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$282,200.00 - $444,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/25/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.