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:
- Planning and Coordination of Regulatory Agency Inspections and Divisional Audits
- Supporting Inspection by Regulatory Agency or Divisional Audit in a key role-Facilitator, Minute Taker, Lead for Document / Request Management Areas.
- Lead Administrator for Inspection/Audit Response Preparation
- As a Site Internal Auditor, independently reviews documents subject to regulatory inspection to ensure compliance to GMPs, international guidelines, MMD policies and departmental SOPs in accordance with QA SOPs.
- 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.
- Support Divisional audits internal to the West Point site and external for benchmarking and development
Note: 5% travel is variable and focused on external training, conferences, and Divisional audits. Qualifications: Education Minimum Requirement:
See below Required Experience and Skills:
Preferred Experience and Skills:
- B.S. degree in scientific or engineering field.
- Minimum 5 years in Pharmaceutical Quality with progressive and demonstrated Quality decision making responsibility.
- Comprehensive GMP System and Shop Floor Auditing Experience.
- Experience Coordinating and supporting Regulatory Agency Inspections in a Key role
- 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.
- In-depth 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.
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