Associate Director Quality

MSD Malaysia; West Point (PA); On-site; USD 129,000 - 203,000; Full time

Job summary

Merck & Co., Inc., Rahway, NJ, USA, seeks an Associate Director within Quality to provide direction and oversight at a site, covering CGMP, training, documentation, annual product review, change control, inspection management, and risk management. Leads a team of Quality Specialists to ensure products are manufactured and tested per approved processes.

The role requires BS or MS in science/engineering with extensive regulatory experience (FDA/EMEA) and strong leadership and continuous

Qualifications

• 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 SupplyChain.
• Master’s degree in Science, Engineering, or another technical field with six (6) years’ experience in a functional area such as Operations, Quality, TechnicalOperations, Technology, Engineering, Maintenance, and/or SupplyChain.

Responsibilities

• Provide quality direction and oversight to one site to ensure CGMP compliance, training, documentation, and quality system processes.
• Lead and develop Quality Specialists and partner with operations to ensure products are manufactured and tested per approved processes.
• Drive quality improvement initiatives and align quality priorities across the organization.
• Ensure compliance with regulatory and internal requirements through risk management and effective inspection management.

Skills

CGMP knowledge

FDA regulations

EMEA regulations

GMP experience

Quality assurance

Leadership

Auditing

Risk management

Education

Bachelor's degree in science/engineering

Master’s degree in science/engineering

Job description

Job Description Summary: The Associate Director within Quality is responsible for providing quality direction and oversight to one of our sites according to our quality systems, including Training, Documentation (including but not limited to Standard Operating Procedures and Master Batch Records), Annual Product Review, 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. This role manages a team of Quality Specialists who are responsible for partnering with the operations and technical operations leaders to ensure that products are manufactured and tested according to approved processes and comply with all applicable regulatory and internal requirements.

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 SupplyChain.
• Master’s degree in Science, Engineering, or another technical field with six (6) years’ experience in a functional area, such as Operations, Quality, TechnicalOperations, Technology, Engineering, Maintenance, and/or SupplyChain.

Required Experience and Skills:

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. Minimum two (2) concurrent years’ experience in the Quality Area in a controlled GMP environment.

Preferred Experience and Skills:

Minimum two (2) concurrent years’ experience managing direct reports. Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Drove a Right First Time culture by implementing continuous improvement initiatives that reduced waste and enhanced operational efficiency. Managed the authoring, review, and approval of compliance documentation, ensuring adherence to regulatory and quality standards. Leveraged a risk-based approach to successfully achieve compliance goals while mitigating operational and regulatory risks. 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 with 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. Production System 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.

#EBRG's #VetJobs Required Skills:

Achieving Objectives, Achieving Objectives, Adaptability, CAPA Management, cGMP Regulations, Coaching, Compliance Activities, Compliance Analysis, Compliance Reporting, Corrective Action Management, Deviation Management, Government Regulation, Laboratory Information Management System (LIMS), Operational Compliance, Operational Quality, People Leadership, Policy Compliance, Proactive Thinking, Procedure Adherence, Process Improvements, Quality Control Management, Quality Manuals, Quality Risk Management, Regulatory Compliance, Regulatory Experience {+ 7 more} Preferred Skills: US and Puerto Rico Residents Only:

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

LosAngeles 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 LosAngeles’ Fair Chance Initiative for Hiring Ordinance

SearchFirm 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: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Cleaning Supplies, BLS-2 Manufacturing Job Posting End Date: 09/19/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.

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 salary range for this role is $129,000.00 - $203,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.