AVP, External Quality
MSD Ireland
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Job summary
Merck (MSD) seeks a head of External Manufacturing Quality for large molecule biologics and vaccines. You will lead a global team (~100) across the external manufacturing network, shaping quality strategy, governance, and oversight while ensuring GMP compliance and supply continuity.
You will partner with senior leaders, drive risk-based oversight across ~30 sites, and guide investigations, technology transfers, and major regulatory interactions.
Qualifications
- Minimum 10 years in Quality Systems/QA/Quality Control within pharma manufacturing under global GMP.
- Experience leading quality oversight of contract manufacturers in regulated environments (FDA/cGMP).
- Proven track record managing complex investigations and risk assessments.
- Strong regulatory compliance background with inspections experience.
- Experience across QA operations including labs, batch release, and systems.
Responsibilities
- Lead global External Manufacturing Quality team (~100 professionals).
- Establish risk-based quality oversight for ~30 external sites (cell banking to packaging).
- Oversee external manufacturer quality to ensure compliance and timely release.
- Drive product releases and coordinate releases for supplier materials.
- Lead major quality investigations and regulatory notifications as needed.
- Support technology transfers, product launches, and inspections.
- Engage with external partner leadership to strengthen quality systems.
- Review audit outcomes and ensure CAPAs are defined and closed.
Skills
Education
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.
- 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.
- Bachelor’s degree in a scientific discipline required
- Advanced degree preferred
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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}
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, 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:
EEOC Know Your Rights
EEOC GINA Supplement
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.
The salary range for this role is $282,200.00 - $444,200.00
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.
The application deadline for this position is stated on this posting.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
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