Associate Director, Quality Assurance

Merck & Co.; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Paid holidays

Sick leave

Job summary

Merck & Co. seeks an Associate Director, Inspections to lead regulatory inspections readiness and Health Authority reporting for West Point Manufacturing and Quality Control laboratories. You will drive compliance programs, monitor regulatory changes, and coordinate inspections with a matrix team across Operations, Regulatory, and Tech.

A strong leadership track record is essential. You will oversee a team of compliance professionals, ensure alignment with 21 CFR Part 11 and Annex 11, and

Qualifications

• Applicable experience, strong understanding and knowledge of relevant quality systems expectations in the biotechnology or vaccine industry.
• Expert knowledge of cGMP relevant to the biotechnology or vaccine industry including knowledge of the local and international GMP regulations.
• In-depth knowledge of regulatory requirements and guidelines (e.g. 21 CFR part 11, Annex 11).
• Ability to work independently while fostering collaboration in team settings and matrix organizations to achieve common goals.
• Highly skilled in listening to diverse perspectives, developing impactful solutions, and advocating for effective positions through influence.
• Strong working knowledge of Quality Management Systems, and associated business processes.
• Excellent communication, leadership, technical writing and problem-solving skills
• Ability to cultivate positive, transparent, and productive relationships across various stakeholders.
• A team player with high initiative, demonstrated planning skills, proven performance in problem-solving, team building and staff development.
• Experience in working with cross functional teams as well as good leadership skills in a matrix organization
• Experience in managing cross-functional initiatives or programs

Responsibilities

• Develop and implement comprehensive compliance program for the site to ensure Permanent Inspection Readiness (PIR), which includes Health Authority Reporting and inspection readiness team.
• Track and Interpret changes in regulations, industry standards and ensure proactive awareness and PIR at the site.
• Conduct regular compliance risk assessments, identify potential risks and develop strategies to mitigate the risks. Identify and address compliance issues, develop corrective action plans and implement improvements to compliance programs
• Act as a liaison and/or SME to present operational compliance to Health Authorities and regulatory agencies on relevant topics.
• Lead a team of professionals who serve as contact for regulatory agencies during inspections, responding to inspectional or regulatory agency inquiries, providing information and addressing compliance concerns.
• Serve as Manager to the lead for the team coordinating Health Authority reporting, Market action events, and complaint process management for the site.
• Provide training and guidance to employees on compliance related matters, ensuring a robust PIR at the site.
• Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for new product launches
• Skills in engaging and collaborating with various functional teams (e.g., Operations, Technology, Automation, Regulatory, Research).
• Ability to build relationships and work effectively in a team-oriented environment.
• Engage and drive continuous improvement initiatives across the site to drive simplification and standardization.

Skills

Change Management

CSV (Computer System Validation)

Decision Making

Driving Continuous Improvement

GMP Laboratory

People Leadership

Performance Qualification (PQ)

Quality Auditing

Quality Control Documentation

Quality Management Standards

Quality Management Systems (QMS)

Quality Risk Management

Regulatory Compliance

Supplier Quality Management

Training and Development

Education

Bachelor's degree

Master's degree

Job description

Job Description The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.

The Associate Director, Inspections lead will be a core member of the West Point Quality Assurance Leadership Team and serves as a quality leader accountable for the quality oversight and management of the Quality team overseeing Regulatory Inspections and Health Authority reporting supporting the West Point Manufacturing and Quality Control laboratories. The position will be responsible to ensure site's compliance with applicable regulations, industry standards and Quality Management Systems. The incumbent will be responsible for developing, implementing and leading a group of compliance professionals through the deployment of compliance programs, monitor compliance efforts and advise site senior management on compliance related matters. The role involves serving as the lead for regulatory agency inspection coordination and collaborating with other departments to address compliance issues. The responsibilities of this role will additionally include sustainment through continuous improvement of the organization at the site.

Primary activities include, but are not limited to:

• Develop and implement comprehensive compliance program for the site to ensure Permanent Inspection Readiness (PIR), which includes Health Authority Reporting and inspection readiness team.
• Track and Interpret changes in regulations, industry standards and ensure proactive awareness and PIR at the site.
• Conduct regular compliance risk assessments, identify potential risks and develop strategies to mitigate the risks. Identify and address compliance issues, develop corrective action plans and implement improvements to compliance programs
• Act as a liaison and/or SME to present operational compliance to Health Authorities and regulatory agencies on relevant topics.
• Lead a team of professionals who serve as contact for regulatory agencies during inspections, responding to inspectional or regulatory agency inquiries, providing information and addressing compliance concerns.
• Serve as Manager to the lead for the team coordinating Health Authority reporting, Market action events, and complaint process management for the site.
• Provide training and guidance to employees on compliance related matters, ensuring a robust PIR at the site.
• Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for new product launches
• Skills in engaging and collaborating with various functional teams (e.g., Operations, Technology, Automation, Regulatory, Research).
• Ability to build relationships and work effectively in a team-oriented environment.
• Engage and drive continuous improvement initiatives across the site to drive simplification and standardization.

Required Experience, Skills, and Knowledge

• Applicable experience, strong understanding and knowledge of relevant quality systems expectations in the biotechnology or vaccine industry.
• Expert knowledge of cGMP relevant to the biotechnology or vaccine industry including knowledge of the local and international GMP regulations.
• In-depth knowledge of regulatory requirements and guidelines (e.g. 21 CFR part 11, Annex 11).
• Ability to work independently while fostering collaboration in team settings and matrix organizations to achieve common goals.
• Highly skilled in listening to diverse perspectives, developing impactful solutions, and advocating for effective positions through influence.
• Strong working knowledge of Quality Management Systems, and associated business processes.
• Excellent communication, leadership, technical writing and problem-solving skills
• Ability to cultivate positive, transparent, and productive relationships across various stakeholders.
• A team player with high initiative, demonstrated planning skills, proven performance in problem-solving, team building and staff development.
• Experience in working with cross functional teams as well as good leadership skills in a matrix organization
• Experience in managing cross-functional initiatives or programs

Minimum Education Requirements and Experience

• Bachelor's degree (BS) or -Master's degree (MS) with Ten (10) years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations.

Preferred Qualifications

• Experience leading regulatory inspection readiness and Health Authority inspections in a pharmaceutical, biotech, or vaccine environment
• Strong knowledge of quality systems, compliance oversight, and CAPA management
• Demonstrated ability to lead cross-functional initiatives in a matrix environment
• Experience interacting with regulatory agencies and senior leadership
• Strong understanding of health authority reporting, complaint management, and market action processes
• Ability to interpret complex regulations and translate them into practical site-level actions
• Proven leadership, coaching, and team development skills
• Excellent communication, influence, and relationship-building skills
• Strong organizational and problem-solving skills with a continuous improvement mindset
• Experience driving simplification, standardization, and process improvement across a site #EBRG's #VetJobs

Required Skills

Change Management, Computer System Validation (CSV), Decision Making, Driving Continuous Improvement, GMP Laboratory, People Leadership, Performance Qualification (PQ), Quality Auditing, Quality Control Documentation, Quality Management Standards, Quality Management Systems (QMS), Quality Risk Management, Regulatory Compliance, Supplier Quality Management, Training and Development

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.

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

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.

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.

The salary range for this role is

$142,400.00 - $224,100.00

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.