Associate Director Quality

MSD; Upper Gwynedd Township (Montgomery County); On-site; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid holidays

Vacation and sick days

Job summary

Merck in the United States seeks an Associate Director, Quality Lead for a Drug Substance capital project. You will oversee quality systems, partner with operations, and ensure compliance with cGMPs and regulatory requirements across design, qualification, and approval phases.

You will interact with regulatory inspectors during pre-approval inspections, demonstrate strong analytical and leadership capabilities, and drive cross-functional collaboration to achieve site priorities.

Qualifications

• Bachelor’s degree with 8+ years in Operations, Quality, Technology or related field; or Master’s with 6+ years.
• Experience in CGMPs and regulatory standards (FDA/EMEA) and a strong compliance mindset.
• Experience managing direct reports (2+ years).
• Knowledge of quality systems, deviation handling, CAPA, change controls.

Responsibilities

• Execute quality system functions relating to GMP compliance and lead multi-department teams.
• Ensure adherence to company policies and all applicable regulations.
• Ensure safety and environmental policy compliance across the team.
• Participate in governance committees, operations reviews, and regulatory forums.
• Acquire and maintain technical process knowledge to support decision making.
• Review and approve compliance documents (deviations, CAPA, change requests).
• Serve as primary Quality lead for Capital Project design, qualification and approvals.

Skills

People management

CGMP/FDA/EMEA knowledge

Analytical thinking

Cross-functional collaboration

Problem solving

Regulatory alignment

Education

Bachelor’s Degree in Science/Engineering

Master’s Degree in Science/Engineering

Job description

Job Description

Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment with our incredibly high standards of quality while meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Associate Director within Quality is responsible for providing quality direction and oversight to a Drug Substance capital project according to our quality systems, including Training, Documentation, Change Control, Inspection Management, Quality Management System, and Risk Management to maintain compliance with regulatory requirements.

The individual is an advocate and leader for the development, execution, and deployment of the site and end-to-end priorities. The Associate Director drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas. The Associate Director is responsible for quality oversight of the Capital Project and the associated Quality Systems.

The qualified candidate ensures compliance with divisional, company, and site standards and procedures.

This is an individual contributor role and partners with the operations and technical operations leaders to ensure that the facility will be designed and qualified in alignment with approved processes and comply with all applicable regulatory and internal requirements.

The selected candidate will play an active role in regulatory inspections, interacting directly with regulatory inspectors when the facility moves to pre-approval inspections. The qualified candidate must demonstrate strong analytical and scientific acumen to assist with the troubleshooting of processes and systems, as well as excellent leadership capabilities. These include cross-functional collaboration, written and verbal communication skills, structured problem solving skills, disciplined decision-making, and talent management experience.

Essential Functions and Responsibilities (Includes, but are not limited to)

The Associate Director, Quality Lead, is responsible for:

• 1.) Executing quality system functions relating to GMP compliance, and coordinating and directing multi-department teams to support ongoing maintenance and enhancements of the quality system(s)
• 2.) Ensuring personnel operate within established policies and procedures of our company and in compliance with cGMPs and all applicable government regulations.
• 3.) Ensuring that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental)
• 4.) Serving on local and site governance committees, Technical/Operations Reviews, and regulatory forums, as well as participating and driving strategic initiatives.
• 5.) Acquiring and maintaining technical process knowledge to support critical thinking and decision making.
• 6.) Reviewing and approving compliance documents such as deviations, corrective / preventive actions, commitments, and change requests.
• 7.) Primary Quality lead for Capital Project support in design, qualification and approval phase.

Minimum Education Requirements and Experience

• Bachelor’s Degree in Science, Engineering, or another technical field with eight (8) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain OR
• Master’s degree in Science, Engineering, or another technical field with six (6) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain

Required Experience and Skills

• Minimum two (2) concurrent years’ experience managing direct reports.
• Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.

Preferred Experience and Skills

• Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible for authoring, reviewing and approving compliance documents. Has experience and proven ability to achieve compliance goals, through a risk-based approach. Has a deep understanding of GMP and EHS compliance and compliance risk.
• Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, and negotiation skills to work outside boundaries as a norm.
• Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
• Demonstrated experience interacting site, divisional or regulatory auditors.
• Demonstrated ability to create an engaged and inclusive workforce
• Demonstrated knowledge of high performing organization tools and methodology, including lean processing and Inclusion. Our Company Production System (MPS) experience - LSS Green Belt certification or equivalent experience.
• Demonstrated success with Talent Management including leading, coaching and mentoring.
• Proven ability to manage multiple projects simultaneously.
• Applies knowledge of internal/external business challenges to improve products, processes, or
• services.
• Solves complex problems; takes a new perspective using existing solutions.
• Works independently, receives minimal guidance.
• Demonstrated self-starter with capability to develop innovative solutions to challenges.
• Aseptic/sterile processing experience.
• Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing.

Required Skills

Aseptic Processing, Aseptic Processing, Audit Management, Business Alignment, Business Decisions, cGMP Training, Change Controls, Coaching, Compliance Activities, Compliance Reporting, Critical Thinking, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, Government Regulation, Logical Thinking, Operational Compliance, Operational Quality, Policy Compliance, Procedure Adherence, Quality Control Documentation, Quality Management Systems (QMS), Quality Metrics, Quality Risk Management {+ 9 more}

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - Pennsylvania - West Point

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$129,000.00 - $203,100.00

This range reflects the Company’s reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

11/4/2026

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