Job Description
The Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. Collaboration is required with site leadership, regional compliance leadership and Divisional Quality Assurance to elevate site audit program to achieve excellence and ensure program is effective. The position requires ability to lead and perform the operational aspects of the audit program, apply risk-based principles, communicate results to stakeholders, and evaluate/verify CAPA closure. Position requires risk communication related to the totality of audit and inspection findings at the site. Ability to lead an audit program that is focused on early detection and robust remediation of observation across the site. Ability to play a lead role in hosting Health Authority inspections and Divisional Audits at the site.
Position Responsibilities:
Actively manage, mentor, and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program
Function as a change agent related to culture and audit program performance
Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics
Perform routine risk communication pertaining to audits/inspection to Site, Regional, and Divisional Management
Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities
Achieve and maintain auditor qualification status through robust training and continuing education
Lead training/orientation for new Quality Auditing staff
Ensure preparation of annual audit schedule, using risk-based approaches
Schedule and perform assigned audits for site program.
Ensure timelines and quality of content for audit execution (audit pre-work, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations.
Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites
Review, and approve Audit Reports
Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management
Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program
Review and ensure CAPA responses to Audits and Inspections are robust
Perform a risk-based verification and effectiveness check on key CAPAs from audits and inspections
Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards
Lead company and site preparation activities for support of regulatory and customer inspections
Provide compliance advice to site, development and commercial product teams
Supports and continually enhance the ongoing site Permanent Inspection Readiness status
Obtain and maintain cutting-edge knowledge and auditing techniques across applicable technical/Quality topics
Education Minimum Requirement:
Bachelor's degree in engineering, Biology, Chemistry or related field
Required Experience and Skills:
Minimum of five (5) years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment
GMP Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements
Knowledge of Quality Systems within a GMP environment
Demonstrated ability to establish and maintain collaborative relationships with key stakeholders
Ability to work independently with limited supervision
Ability to build relationships and influence across disciplines and all levels
Preferred Experience and Skills:
GMP Audit experience in the pharmaceutical industry (CQA or other certification preferred)
Experience with leading effective audits and obtaining meaningful audit observations
“Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas, based on site activities; Medical Device/Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product
Specific technical knowledge in areas pertaining to the hiring site (e.g, Quality Systems, Manufacturing, Testing/Stability, Microbiology testing, Packaging, Distribution, Data Integrity, Automation)
Knowledge of QBD development & submission requirements, as applicable to site
Ability to lead, motivate, develop and mentor other auditors
Knowledge of and experience in Quality Risk Management methods
Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable
Experience with hosting or participating in Health Authority inspections and/or Divisional audits
Highly motivated, flexible, and have excellent organizational and communication skills
Excellent verbal and written communication skills
Ability to prioritize and balance work from multiple projects in parallel
Required Skills:
Accountability, Accountability, Aseptic Processing, Audit Management, Biological Sciences, cGMP Training, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, GMP Compliance, Immunochemistry, Internal Auditing, IS Audit, Management Process, Medical Devices, Molecular Microbiology, Quality Auditing, Quality Control Documentation, Quality Control Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management, Regulatory Compliance Consulting {+ 5 more}Preferred Skills:
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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
$126,500.00 - $199,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An 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
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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:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
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NoHazardous Material(s):
N/AJob Posting End Date:
12/24/2025*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.