Associate Director Quality

Merck & Co.; West Point (PA); On-site; USD 129,000 - 203,000; Full time

Job summary

Merck & Co. is seeking an Associate Director of Quality to provide direction and oversight for our site’s quality systems, including training, documentation, change control, and inspection management.

The role leads a team of Quality Specialists to ensure products are manufactured and tested in compliance with regulatory and internal standards. The candidate will drive continuous improvement, maintain CGMP compliance, and collaborate across operations to align on priorities and risk management.

Qualifications

• Bachelor's degree in science, Engineering, or another technical field with eight (8) years' experience in a functional area.
• Master's degree in Science, Engineering, or another technical field with six (6) years' experience in a functional area.
• Strong understanding of CGMPs, FDA, and EMEA regulatory standards.
• Minimum two (2) concurrent years' experience in the Quality Area in a controlled GMP environment.

Responsibilities

• Provide quality direction and oversight to site according to quality systems.
• Lead development, execution, and deployment of site priorities.
• Manage a team of Quality Specialists working with operations leaders.
• Ensure products are manufactured and tested per approved processes and compliance requirements.

Skills

CGMPs

FDA/EMEA

Analytical thinking

GMP environment

Auditing

Quality leadership

Direct reports

Risk management

Lean processing

Aseptic processing

Pharma manufacturing

Education

Bachelor's degree

Master's degree

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 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 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 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. 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 .

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

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

Cleaning Supplies, BLS-2 Manufacturing