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 Director, West Point Quality Systems, reports to the Director, West Point Quality Assurance, and supports all Quality Assurance and GMP compliance activities relating to the manufacture of pharmaceutical and vaccine products to ensure compliance with all applicable regulations and specifications.
1. Directly leads activities in the execution of quality system functions relating to pharmaceutical and vaccine GMP compliance; additionally, is frequently called upon to champion multi-department, site-based teams regarding various compliance initiatives and assessments.
2. Coordinates and directs teams of multi-disciplined professionals in areas of process and systems, as they relate to quality system enhancements.
3. Oversees the execution, robustness and performance improvement of a subset of key Quality Systems, that could include:
a. Change control and Automation Change Control
b. Documentation, including SOPs and batch records
c. Records retention
d. Quality Oversight of JLL owned tasks
Note: Annual Product Reviews; Agency reporting of BPDRs and FARs, and market actions; Internal auditing; CAPA and Commitment management are key systems that may require support but are not within the direct oversight of the role.
4. Uses available information channels to maintain compliance proficiency, and utilizes this information to identify and evaluate emerging trends for incorporation to Quality Systems requirements. These information channels include:
a. Participation in regulatory inspections
b. Review of inspection reports from other sites/agencies and regulatory agency publications
c. Attending and participating in local quality forums, industry working groups, or internal teams as needed
5. Acts as the primary liaison to support Quality System enhancements as required by a variety of signals (e.g. inspection outcome, regulatory surveillance, performance improvement need).
6. Responsible for hiring and ensuring Quality Assurance personnel are trained, and administers all personnel policies and development programs. Ensures personnel operate within established policies/procedures of Merck and in compliance with cGMPs and all applicable governing regulations.
7. Utilizes personnel capacity in an efficient manner to ensure on-time output of customer needs. Qualifications:
- Bachelor's degree in an appropriate scientific or engineering field of study is required.
- Preferred fields of study include Biology, Biochemistry, and Microbiology. An MBA or other business degree, in addition to the required science or engineering education, is a plus.
Required Experience and Skills:
- At least eight (8) years of work experience in a medical device, pharmaceutical, biologic and/or vaccine manufacturing environment or a strongly related, similarly regulated field.
- Concurrently, four (4) years of managerial experience, with responsibility for direct and indirect reports.
- Strong understanding of cGMPs, FDA and EMEA regulatory standards. Strong compliance mindset.
- Excellent writing skills.
- Strong lean mindset with MPS/Kata capabilities.
- Ability to be self-motivated and work independently, yet collaboratively in team settings and within matrix organizations to achieve objectives.
- Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.
Preferred Experience and Skills:
- Previous work within Sterile/Vaccines manufacturing companies or regulatory authorities.
- Experience in compliance remediation activities at plant sites.
- Experience and/or exposure in Plant audits and Supplier Audits
- Experience in Regulatory Commitments implementation and effectiveness
- Minimum of two (2) different management pathway roles or experiences
- Accountable for actions, drives results, and learns from mistakes.
- Demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions.
- Communicates influences and escalates issues and decisions, as appropriate.
- Goes to the shop floor to see the problems and work directly with people on the shop floor.
- Demonstrates tolerance for ambiguity.
- Experience in CAPAs effectiveness and Implementation
- Previous exposure to documents approval such as: Validation reports, Nonconformance investigations, Work orders and Change controls.
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 email@example.com .
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Visa sponsorship is not available for this position.
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