Associate Director Quality

Merck; West Point (PA); On-site; USD 140,000 - 210,000; Full time

Job summary

Merck is seeking an Associate Director of Quality to provide strategic quality direction for a site in the United States. The role emphasizes CGMP compliance, regulatory alignment, training, documentation, and risk management to sustain regulatory readiness and product quality.

A leadership pipeline with a focus on continuous improvement and cross-functional collaboration is essential. The position manages a team of Quality Specialists, driving Right First Time outcomes, authoring and approving

Qualifications

• Bachelor's degree with 8+ years in quality, operations, or related area.
• Master's degree with 6+ years in quality/operations or technical fields.
• Strong CGMP, FDA/EMEA knowledge and compliance mindset.

Responsibilities

• Provide quality direction and oversight to the site following quality systems and processes.
• Lead a team of Quality Specialists and partner with operations leaders to ensure compliant manufacturing and testing.

Skills

cgmp compliance

regulatory knowledge

leadership

quality systems

risk management

project management

auditing

Education

Bachelor's degree in science/engineering

Master's degree in science/engineering

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 Supply Chain.
• 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:

• 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}

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.

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 orie