Senior Specialist Quality Compliance GMP Audit 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.
The position is primarily responsible for executing and leading internal and external GMP audits following Merck's auditing policy and guidance to ensure compliance with worldwide regulatory expectations. This includes ensuring that facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with Merck requirements and applicable global regulations.
Responsible to achieve and maintain qualification / certification status through robust training and continuing education programs to enable conducting audits of Human Health, Animal Health and Consumer Care Sites, Contracted facilities, Distribution Centers, Business Partners and Suppliers. Responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes. The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, GMP documentation as well as extensive communication and partnership with divisional oversight groups and commercial sites.
- Schedule and perform assigned audits and ensure timelines for audit steps (prework, conducting audit, issuance of audit report, CAPA receipt) meet established expectations. This requires approximately 50% worldwide travel.
- Review and approve audit reports.
- Maintain a broad based expertise of cGMP's, Merck Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Vaccines, Small Molecules, Combination Products, APIs and Controlled Substances.
- Obtain and maintain cutting-edge knowledge, application, and certification status for various technical/Quality auditing topics
- Maintain awareness of evolving industry and regulatory trends/regulations. Support New Business opportunities through Due Diligence (electronic due diligence as well as on-site visits) and Pre-Contract Audits, issuance of reports, and evaluation of corrective and preventive actions. Assist with preparation of annual audit schedule, using risk based approaches for auditor assignment
- Lead & Coordinate with Procurement and impacted Site Quality leads on critical audit findings and or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed.
- Provide regulatory inspection support to Merck Sites as it relates to the Divisional Audit program, status of audits, and specific audit results.
- Provides support and administrative functions for the electronic Supplier Tracking and Repository System, and assists in data maintenance.
- Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet using site, management and regulatory expectations.
Education Minimum Requirement:
- Bachelor Degree in Engineering, Biology, Chemistry or related field
Required Experience and Skills:
- Minimum of 5 years of manufacturing, technology, and/or quality experience within an FDA, and/or EU API, Drug Product, Medical Device or equivalent environment.
- Experience performing audits of external and internal manufacturers and testing laboratories. Must have a working knowledge of processes to support the manufacturing of APIs and Drug Products.
- Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
- Ability to travel globally approximately 50% of the time.
- Ability to work independently with limited supervision in a virtual-management environment
- Excellent/accomplished communication, negotiation, and facilitation skills.
Preferred Experience and Skills:
- Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
- Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives
- Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas
- Lean six-sigma belt / demonstrated process improvement experience
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: Quality GMP Related
Job Title:Sr. Spclst, Quality Systems & Compliance
Primary Location: NA-US-NJ-Whitehouse Station West
Other Locations: NA-US-PA-West Point, NA-Puerto Rico, NA-United States
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New Jersey
Job Segment: Audit, Medical, Compliance, Law, Engineer, Finance, Healthcare, Legal, Engineering