Executive Director, Quality Systems & Compliance
Executive Director, Quality Systems & Compliance
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$ 227300 - 357900
1 Vacancy
Job Description
Job Description
Primary Activities:
Oversee the Compliance Remediation and Support (CRS) team within Global Quality Compliance Support.
Provide compliance leadership and direction to our company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API) biologics and vaccine drug substances finished products and combination products.
Oversee quality systems pertaining to health authority inspections inspection and audit CAPA site internal audit programs and GMP-related regulatory communications.
Oversee program to ensure CRS support to sites before during and after health authority inspections and provide enhanced support for inspections deemed to be high risk
Oversee program to ensure CAPA are effectively implemented
Oversee program to support remediation of significant GMP compliance risks within the network
Oversee health authority reporting program to ensure compliance to global regulatory reporting requirements (e.g. Field Alert Reports (FARs) Biological Deviation Reports (BPDRs) Defective Product Reports (DPRs))
Support audit program by identifying audit targets and help develop protocols for targeted assessments
Support network observation sharing program by ensuring that appropriate global actions are taken in response to inspectional findings at network sites
Support external advocacy initiatives and internal knowledge management initiatives via active participation in industry organizations such as PDA PQRI PhRMA ISPE etc.
Education Minimum Requirement:
B.S. M.S. and/or Ph.D. in life sciences chemistry engineering or related relevant discipline
Required Experience and Skills:
A minimum of 10 years of quality operational or technical experience within the pharmaceutical biopharmaceutical vaccine or medical device industry
Expert knowledge of GMP requirements for multiple regulatory agencies
Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS
Experience in health authority inspections a compliance decision-making role preferred
Experience assessing remediation plans
Drive Results set clear performance standards overcome obstacles; accountable for actions and achieve results
Make Rapid Disciplined Decisions demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
Act with Courage and Candor ability and willingness to advocate for compliance position using objective evidence escalates issues and decisions as appropriate
Foster Collaboration ability to influence facilitate groups with diverse perspectives bring teams to consensus/alignment
Build Talent build talent with the capabilities necessary to succeed in our markets; inspire reward and develop to ensure individuals reach their potential; make tough calls when necessary
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
$227300.00 - $357900.00This 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:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Biological Sciences Biopharmaceuticals Business cGMP Compliance Combination Products Cross-Cultural Awareness Customer-Focused Data Analysis Detail-Oriented Ethical Standards GMP Compliance Mentoring Staff Microbiology People Leadership Pharmaceutical Management Pharmaceutical Manufacturing Process Improvements Quality Management Systems (QMS) Regulatory Inspections Regulatory Reporting Sterile ProcessingPreferred Skills:
Job Posting End Date:
06/12/2025*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:
Director
Employment Type
Full-Time
