Associate Director, Site Lead GMP Auditor Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This individual is responsible for the execution of audits to ensure compliance with appropriate government regulations, company policies, and departmental SOPs. The Lead Auditor will ensure that the current regulations, policies, and procedures are adhered to at the West Point Merck site.
This individual serves as a Matrix Manager, directing and mentoring the auditing work of 50+ Site Auditors. The incumbent attends external conferences, as well as training, and cascades information to Site Auditors along with key stakeholders.
Understands and applies regulatory/compliance requirements relative to their role. Has developed conceptual and practical expertise in own discipline. Applies knowledge of internal/external processes to drive improvements. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance. Acts as a resource for colleagues with less experience within own discipline. Promotes teamwork and open discussion of issues, coaches and guides others.
Effectively communicates complex issues to all levels and works to build alignment around a complex situation. Makes decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities.
Primary activities include, but are not limited to:
- Training and Mentoring 50+ West Point site GMP Auditors.
- Independently functioning as a Lead Auditor, reviews documents subject to regulatory inspection to ensure compliance to GMPs, international guidelines, MMD policies and departmental SOPs in accordance with QA SOPs.
- Independently, functioning as a Lead Auditor, conducts site evaluations to assess compliance to regulatory requirements and/or MMD standards.
- Assures timely resolution of findings and reports all findings to appropriate personnel and management.
- Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information.
- Participates on, or leads teams supporting internal functions and/or evaluating site processes for improvement opportunities.
- Completes special projects or assignments as directed by management including conducting education and training on GMP requirements and auditing other areas of responsibility including external vendor audits.
- Attends external conferences and training.
- Ad-Hoc attendee at the West Point site Quality Council for all auditing topics.
- Support Divisional audits internal to the West Point site and external for benchmarking and development.
- QMS owner for all site auditing functions.
- Individual may have the opportunity to support other areas within the MMD West Point Quality Assurance organization, including:
- Change Control, SOP and Batch Record Management
- Automation Compliance
- Deviation Management
- Annual Product Reviews, Vendor Management
- Inspection Management, QMS / Quality Council Management
- Risk Management
- Market Actions
Note: 10% travel is variable and focused on external training, conferences, and Divisional audits.
- B.S. or M.S. degree in scientific or engineering field.
- Minimum 10 years in Pharmaceutical Quality with progressive and demonstrated Quality decision making responsibility.
- Comprehensive GMP System and Shop Floor Auditing Experience.
- Experience directly managing and developing a team.
- Demonstrated success working in a Matrix Manager role.
- Project Management, Change Execution Management and Team Leadership experience in a Quality function.
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
- Demonstrated self- starter with capability to develop innovative solutions to challenges.
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
- Strong written and verbal communication skills.
- Working knowledge and application of GMPs.
- Proven ability to manage multiple projects simultaneously.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Qual Assurance & Ops Generic
Job Title:Assoc. Dir, Quality Assurance
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Hazardous Materials: This position requires the employee to enter core sterile manufacturing areas
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Audit, Pharmaceutical, Records Management, Animal Health, Manager, Finance, Science, Records, Veterinary, Management