Director, Quality Systems & Compliance
Job Description
Our Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Summary, Focus and Purpose
The Director of GMP Compliance will report to the head of the Global Quality Compliance Support organization. The responsibility of this position crosses all Human & Animal Health operating units and requires extensive partnership with manufacturing sites and global GMP SMEs.
Key Functions
- Serve as a subject matter expert for good manufacturing practices for drug products, active pharmaceutical ingredients, biologics, vaccines, and devices
- Ensure that global QMS documents meet major health authority GMP requirements
- Provide consulting and research services to global QMS topic owners and site quality experts to assess the compliance impact of potential updates to our company’s policies and procedures
- Oversee a program to prevent repeat health authority observations throughout the Manufacturing Division network and to share knowledge of relevant findings with key stakeholders
- Serve as the global topic owner for regulatory inspections, audit & inspection CAPAs, and network observation sharing
- Maintain an internal library of GMP-relevant information and make use of external databases for consultative services
- Provide GMP compliance guidance and assistance before, during, and after major health authority inspections
- Maintain a network of external peers in the regulated industry through appropriate forums (e.g., PDA, PQRI, PhRMA, ISPE, etc.) guide regulatory benchmarking activities
Education Minimum Requirement and Experience
- Bachelor’s Degree (B.S.) with a preference in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with ten (10) years of quality, operational, or technical experience within the GMP regulated environment, OR
- Master’s Degree (M.S.) with a preference in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with eight (8) years of quality, operational, or technical experience within the GMP regulated environment, OR
- PhD with a preference in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required with five (5) years of quality, operational, or technical experience within the GMP regulated environment
Required Knowledge and Skills
- Expert knowledge of GMPs and regulatory requirements and expectations.
- Experience and exposure (not less than 5 years) in managing health authority inspections and communications in a pharmaceutical or biotechnology manufacturing site.
- Strong background in data analytics
- Demonstrated ability to creatively use multiple methods of analysis to decipher large datasets, including text-based and unstructured datasets
- Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
- Accountable for actions, drives results, and learns from mistakes
- Demonstrates good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions
- Communicates, influences, and escalates issues and decisions, as appropriate
- Communicates effectively up and down, at all levels of the organization
- Demonstrates tolerance for ambiguity
- Able to travel up to 20% of the time
Preferred Experience and Skills
- A minimum of 15 years of quality, operational, or technical experience within the GMP regulated environment
- Experience working for a health authority/board of health as an inspector, product reviewer, compliance officer, or other GMP/regulatory role
- Strong background and technical understanding of vaccines and/or biologics
- Expert knowledge of international GMPs/requirements of multiple regulatory agencies
Current Employees apply HERE
Current Contingent Workers apply HERE
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.
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:
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
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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Required Skills:
Business, Change Management, Compliance Remediation, Compliance Reviews, Cross-Functional Leadership, Detail-Oriented, Employee Training Programs, ICH Q10, Innovation, IS Audit, Management Process, Mentoring Staff, Pharmaceutical Regulatory Compliance, Policy Development, Process Facilitation, Process Improvements, Quality Improvement Programs, Quality Management, Regulatory Compliance Audits, Regulatory Reporting, Standards Compliance
Preferred Skills:
Job Posting End Date:
06/23/2025*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: R352924