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Job Description

We are hiring a Quality Compliance Director to join the West Point Quality Assurance Leadership Team. 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, and suppliers; our team creates a global manufacturing network dedicated to deliver a compliant, reliable supply to customers and Patients on time, every time, across the globe.

The Quality Compliance Director will drive FDA and global inspection readiness, oversee site internal audits and Health Authority reporting, design strategic corrective actions, and develop a high-performing compliance team. The role ensures site compliance with cGMP and applicable regulations and leads continuous improvement of compliance systems.

Key responsibilities:

+ Lead FDA and Health Authority inspection readiness and responses; coordinate mock inspections, on-floor support, and regulatory communications.

+ Build and maintain a Permanent Inspection Readiness (PIR) and internal audit program to detect gaps and monitor CAPA effectiveness.

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

+ Lead root-cause analysis and develop prioritized, measurable corrective and preventive actions; verify effectiveness with clear KPIs.

+ Manage, coach, and grow a team of compliance professionals and internal auditors; set expectations and succession plans.

+ Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for new product launches

+ Oversee Health Authority reporting (BPDRs, DPRs, FARs), market action events, and complaint assessment and reporting decisions.

+ Works with responsible teams to author and submit the required health authority notification and any follow-up action.

+ Partner cross-functionally (Operations, Regulatory, QC, R&D, Supply Chain) and with external suppliers to drive compliance.

+ Drive simplification and continuous improvement of quality systems and supplier compliance monitoring.

Qualifications

+ BA/BS and 10+ years leading quality audit/inspection strategies in large-molecule biologics or vaccines with strong FDA experience.

+ Deep knowledge of cGMP, FDA inspection expectations, and relevant regulations (e.g., 21 CFR Part 11, Annex 11).

+ Proven inspection management and PIR experience; experienced in authoring regulatory submissions and responses.

+ Strong strategic thinking, analytical problem-solving, and CAPA management skills.

+ Demonstrated people leadership in a matrix organization: hiring, coaching, performance management, and team development.

+ Excellent communication, technical writing, project management, and stakeholder influence skills.

Required Skills:

Audit Inspections, Change Management, Coaching, FDA Inspections, FDA Regulations, Interpersonal Relationships, Leadership, Management Process, People Leadership, Quality Auditing, Quality Compliance, Regulatory Compliance, Risk Management, Strategic Thinking, Team Development

Preferred Skills:

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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

Job Posting End Date:

11/5/2025

*A job posting is effective until 11:59:59PM on the day** **BEFORE** **the 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