Executive Director, Global GMP Auditing

Job Description

The Executive Director of Global Auditing will report to the Head of Global Quality Compliance Support.- The responsibility of this position crosses Human and Animal Health operating units and requires extensive collaboration with manufacturing sites, contractors, and suppliers.-

Primary Responsibilities:

• Lead global team of GxP auditing experts to ensure our company's manufacturing sites, contractors, and suppliers adhere to the highest quality and compliance standards
  
• Develop and maintain global Quality Management System (QMS) documents pertaining to auditing and inspections; ensure team and company adherence to these documents
  
• Develop a risk-based audit schedule for our company's auditable entities and ensure schedule adherence
  
• Ensure audits are conducted to assess compliance with applicable regulations/ guidelines, customer requirements, SOPs and project specific guidelines/ instructions.
  
• Evaluate audit findings and ensure timely identification/ escalation of potential critical observations and compliance gaps observed during audits.
  
• Develop and maintain a strong training program for auditors to ensure their ongoing skills development and ability to detect and communicate GxP compliance concerns
  
• Ensure fiscal responsibility while maintaining budget for global auditing team
  
• Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.
  
• Provide updates to company stakeholders on GxP and regulatory trends as well as the auditing program's ability to detect compliance to current and evolving expectations.-
  
• Ensure timely identification and escalation of potential critical observations and compliance gaps observed during audits.
  
• Lead high-risk or complex audits
  
• Oversee quality and compliance activities within assigned area of focus
  
• Comply with all of our company's corporate guidelines and policies
  

Education Requirement:

• B.S., M.S., and/or Ph.D. in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required.
  

Required Experience and Skills:

• A minimum of 10 years of quality, operational, or technical experience within the GMP regulated environment
  
• Expert knowledge of GMPs and regulatory requirements and expectations.
  
• Strong technical background
  
• 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
  
• Expert knowledge of international GMPs/ requirements of multiple regulatory agencies
  
• Able to travel up to 30% of the time
  

Preferred Experience and Skills:

• A minimum of 15 years of quality, operational, or technical experience within the GMP regulated environment
  
• A minimum of 5 years of auditing experience
  
• A minimum of 5 years leading complex or global teams
  
• Strong background in data analytics
  
• Strong background and technical understanding of vaccines and/or biologics, aseptic techniques, and analytical techniques.-
  
• Experience working for a health authority/board of health as an inspector, product reviewer, compliance officer, or other GMP/regulatory role
  

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:

EEOC Know Your Rights

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

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
$227,300.00 - $357,900.00

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 .

You 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:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:
Accountability, Accountability, Biological Engineering, cGMP Compliance, Chemical Engineering, Communication, Cross-Cultural Awareness, Customer-Focused, Data Analysis, Detail-Oriented, Employee Training Programs, Ethical Standards, GMP Compliance, Immunochemistry, Implement Training Programs, Knowledge Base Management, Management Process, Mentoring Staff, Microbiology, People Leadership, Pharmacokinetics, Pharmacology, Physiology, Phytochemistry, Process Improvements {+ 3 more}

-Preferred Skills:

Job Posting End Date:
08/20/2025
*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: R360832