Director, Global Quality & Compliance Support
Director, Global Quality & Compliance Support
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$ 169700 - 267200
1 Vacancy
Job Description
Job Description
We are seeking a dynamic and experiencedQuality & Compliance Directorto lead GMP compliance across our global network of internal and external contract manufacturing organizations (CMOs). This critical leadership role will collaborate with a network of professionals responsible for the manufacturing of active pharmaceutical ingredients (APIs) and finished products including biologics and vaccines.
As a trusted GMP compliance expert you will drive regulatory excellence support health authority inspections and ensure robust corrective and preventative actions (CAPA) are effectively implemented to maintain the highest quality standards
Key Responsibilities:
GMP Compliance Leadership:Serve as the subject matter expert (SME) on current good manufacturing practices (CGMP) for pharmaceutical manufacturing including large molecule manufacturing guiding compliance for internal and external teams worldwide.
Inspection Readiness & Support:Supports preparation efforts for regulatory audits and inspections including a holistic lifecycle support for pre-approval inspection (PAI) for the companys growing pipeline of products and launches.
CAPA Management:Collaborate with company and CMO teams to develop monitor and verify CAPA plans addressing global audit and inspection findings ensuring timely and effective resolution.
Regulatory Intelligence & Trend Analysis:Gather and analyze regulatory updates and inspection outcomes to identify trends drive improvements and report findings to senior quality and management councils.
Regulatory Consultation: Offers proactive interpretation and consultation to project teams and sites on global pharmaceutical regulations guidelines compliance hot topics policies and procedures.
Industry Engagement:Represent the company in key industry organizations such as PDA PQRI PhRMA and ISPE to stay at the forefront of regulatory and quality best practices.
Qualifications:
Bachelors degree in Life Sciences Chemistry Engineering or a related field.
10 years of progressive experience in Quality Compliance preferably within large molecule manufacturing (biologics and/or vaccines).
Deep expertise in GMP requirements across multiple regulatory agencies (FDA EU ROW)
Strong understanding of different pharmaceutical manufacturing processes including Low Bioburden and sterile operations.
Proven track record supporting health authority inspections and implementing effective CAPA.
Ability to interpret and apply regulatory expectations to maintain a robust Quality Management System (QMS).
Core Competencies:
Drive Results:Set clear goals overcome challenges and deliver measurable outcomes.
Decisive Judgment:Make timely data-driven decisions with confidence and discipline; demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
Courage & Integrity:Advocate for compliance with transparency and escalate issues appropriately.
Collaborative Leadership:Influence and align diverse teams to achieve consensus and shared objectives.
Preferred Experience:
Prior experience working within a health authority as an inspector investigator compliance officer or assessor.
Expertise in developing or evaluating remediation plans following regulatory inspections.
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 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 anothers 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 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
$169700.00 - $267200.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
50%Flexible Work Arrangements:
RemoteShift:
1st - DayValid Driving License:
YesHazardous Material(s):
N/ARequired Skills:
Audit Management cGMP Regulations Change Management Collaborative Leadership Communication Corrective and Preventive Action (CAPA) Decision Making Detail-Oriented Driving Continuous Improvement Global Team Collaboration GMP Compliance Good Manufacturing Practices (GMP) Inspection Readiness IS Audit Management Process Manufacturing Processes Pharmaceutical Manufacturing Quality Improvement Programs Quality Management Quality Management Systems (QMS) Quality Operations Regulatory Compliance Regulatory InspectionsPreferred Skills:
Job Posting End Date:
08/15/2025*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.
Required Experience:
Exec
Employment Type
Full-Time
