Quality Compliance Director

Merck; Pennsylvania; Hybrid; USD 169,000 - 268,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a Quality Compliance Director to oversee compliance efforts within the West Point Quality organization. The candidate will lead a team responsible for ensuring regulatory compliance and continuous improvement initiatives. Required qualifications include a degree in a related field and extensive experience in quality assurance or compliance within the biotech sector.

Benefits

Comprehensive insurance benefits

401(k) retirement plan

Paid holidays and vacation

Qualifications

• 15 years experience in quality assurance, compliance, or manufacturing operations required with a BA/BS.
• 10 years experience with a MA/MS in similar fields.
• Strong understanding of quality systems and compliance in the biotechnology or vaccine industry.

Responsibilities

• Develop and implement compliance programs to ensure inspection readiness.
• Lead regulatory agency inspection coordination and compliance audits.
• Provide training and guidance on compliance related matters.

Skills

Change Management

Coaching

Data Integrity

Decision Making

FDA Regulations

Interpersonal Relationships

Quality Assurance Compliance

Quality Risk Management

Regulatory Compliance

Strategic Thinking

Education

Bachelor’s degree (BA/BS)

Master’s degree (MA/MS)

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. Partnering across our West Point campus, internal manufacturing facilities, external contract manufacturers and suppliers we create a global manufacturing network dedicatedto deliver a compliant, reliable supply to customers and Patients on time, every time, across the globe.

The Quality Compliance Director 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, Site Internal Audit 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 also 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 leading the site audit program and inspection readiness team.

• Track and Interpret changes in regulations, industry standards and ensure proactive awareness and PIR at the site.

• Champion engrained quality culture across the manufacturing site by enhancing learning and awareness of quality systems

• 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

• Coach the site on quality risks to develop near and long term strategies with all operational related risks identified and escalation and mitigation of risks in a timely manner.

• 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 lead for the team coordinating Health Authority reporting, Market action events, and complaint process management for the site.

• Health Authoring Reporting, including but not limited to BPDRs, DPRs, and FARs | Assesses events such as complaints and deviations and determines the need to report the event | Works with responsible teams to author and submit the required health authority notification and any follow-up action.

• Lead a team of site internal auditors to ensure PIR and monitor ongoing compliance activities

• Provide training and guidance to employees on compliance related matters, ensuring a robust PIR and auditing program 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).

• Act as a partner to applicable network teams and communities of practice associated with compliance, facility fitness, inspection readiness, data integrity and other programs as applicable.

• Partner across Quality and other key stakeholders to ensure the monitoring of third party supplier’s compliance with requirements of cGMPs and applicable regulations.

• 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.

Minimum Education Requirements and Experience:

• Bachelor’s degree (BA/BS) with fifteen (15) years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations; OR

• Master’s degree (MA/MS) with ten (10) years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations.

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)

• Expert knowledge with audit or inspection management

• Proven success in delivering compliance initiatives and organizational design/ establishment.

• Exceptional analytical and problem-solving skills, with the ability to distill complex data into actionable insights and recommendations.

• 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

• Very skilled at organizing complex topics, strong project management skills, able to handle multiple tasks concurrently

• Adapts to rapidly changing business needs, fostering a flexible and responsive approach to challenges.

• 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.

• Fosters positive, transparent and productive relationships

• Proven history of challenging the status quo of business standards and processes with the ability to propose solutions

• Experience in working with cross functional teams as well as good leadership skills in a matrix organization

• Proven history of developing strategic plans and implementing on time

• Ability to be decisive and influence management with demonstrated leadership skills and management of large teams.

• Experience in managing cross-functional initiatives or programs

• Understanding and experience in various business methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$169,700.00 - $267,200.00

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

Search Firm 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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

Change Management, Coaching, Data Integrity, Decision Making, FDA Regulations, Interpersonal Relationships, IS Audit, Management Process, Manufacturing Quality Control, Operational Efficiency, People Leadership, Quality Assurance (QA), Quality Assurance Compliance, Quality Auditing, Quality Compliance, Quality Management Standards, Quality Risk Management, Regulatory Compliance, Results-Oriented, Risk Management, Strategic Thinking

Preferred Skills:

People Management

Job Posting End Date:

07/18/2025

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

Requisition ID:R354681