Associate Director Quality

MSD • Upper Gwynedd Township, PA

1d • $129,000 - $203,100 • Onsite

About The Position

The Associate Director, Quality Lead, provides quality direction and oversight for a Drug Substance capital project and its associated Quality Systems. The role supports compliance with the company’s quality systems—including Training, Documentation, Change Control, Inspection Management, Quality Management System, and Risk Management—and with applicable regulatory requirements. The individual partners with operations and technical operations leaders to ensure the facility is designed and qualified in alignment with approved processes and internal and regulatory requirements.

This individual contributor advocates for and leads development, execution, and deployment of site and end-to-end priorities, drives quality improvement, and supports alignment across the organization. The role includes active participation in regulatory inspections and direct interaction with inspectors during pre-approval inspections. The successful candidate applies analytical and scientific judgment to troubleshoot processes and systems and contributes cross-functional leadership, structured problem solving, disciplined decision-making, communication, and talent management expertise.

Requirements

• Bachelor’s degree in Science, Engineering, or another technical field and eight years of experience in a functional area such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, or Supply Chain; alternatively, a master’s degree in one of these fields and six years of relevant functional experience.
• At least two concurrent years of experience managing direct reports.
• Strong understanding of cGMPs and FDA and EMEA regulatory standards, with a strong compliance mindset.
• Proven analytical aptitude, critical-thinking skills, and ability to apply key concepts.
• Strong cross-functional collaboration, written and verbal communication, structured problem-solving, and disciplined decision-making capabilities.
• Ability to interact with regulatory inspectors and support regulatory inspections.
• Ability to troubleshoot processes and systems using analytical and scientific acumen.

Nice To Haves

• Experience creating and sustaining a culture that treats safety, environmental, and cGMP compliance as business imperatives and promotes Right First-Time performance and continuous improvement.
• Experience authoring, reviewing, and approving compliance documents and achieving compliance goals using a risk-based approach; deep understanding of GMP, EHS compliance, and compliance risk.
• Excellent interpersonal, communication, collaboration, and negotiation skills for working across organizational boundaries.
• Ability to use production operations expertise to drive business outcomes.
• Experience interacting with site, divisional, or regulatory auditors.
• Ability to create an engaged and inclusive workforce.
• Knowledge of high-performing organization tools and methodologies, including lean processing and inclusion; Our Company Production System (MPS) experience, LSS Green Belt certification, or equivalent experience.
• Success in talent management, including leading, coaching, and mentoring.
• Ability to manage multiple projects simultaneously.
• Ability to apply knowledge of internal and external business challenges to improve products, processes, or services; solve complex problems using a new perspective on existing solutions; work independently with minimal guidance; and develop innovative solutions.
• Aseptic or sterile processing experience.
• Quality or Operations experience in pharmaceutical, biologics, vaccines, or therapeutic protein manufacturing.

Responsibilities

• Execute quality system functions relating to GMP compliance and coordinate and direct multi-department teams supporting the maintenance and enhancement of quality systems.
• Ensure personnel operate in accordance with company policies and procedures, cGMPs, and applicable government regulations.
• Ensure team members work safely and comply with corporate, site, and government safety and environmental policies and procedures.
• Serve on local and site governance committees, Technical/Operations Reviews, and regulatory forums; participate in and drive strategic initiatives.
• Acquire and maintain technical process knowledge to support critical thinking and decision-making.
• Review and approve compliance documents, including deviations, corrective and preventive actions, commitments, and change requests.
• Act as the primary Quality lead for capital project design, qualification, and approval.
• Provide quality oversight of the Drug Substance capital project and associated Quality Systems.
• Partner with operations and technical operations leaders to ensure facility design and qualification align with approved processes and applicable requirements.
• Participate actively in regulatory inspections and interact directly with regulatory inspectors during pre-approval inspections.
• Drive quality improvement activities and ensure organizational alignment in assigned areas.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior