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 Associate Director within the Quality Assurance Center of Excellence is the 'Voice of Quality' for the Site and is responsible for providing Quality direction and oversight to the WP Site in the management of those areas assigned, such as general End-End Support, Internal Auditing, Training, Annual Product Review, Change Control, Inspection Management, Documentation, Manufacturing Batch Records, MES, Quality Planning, and Risk Management in order to maintain compliance with Regulatory requirements. The individual is an Advocate for the development, execution and deployment of WP Site and MMD priorities. The Associate Director drives quality improvement activities and ensures alignment across the site in the execution of their assigned areas. The individual is responsible for the development and maintenance of Quality Systems at the West Point site in accordance with cGMPs and international regulations, Merck guidelines, procedures, and policies. Ad hoc member of the WP Site Quality Council.
The Associate Director will lead key compliance projects at the site aimed at elevating our compliance posture. Project Managers are expected to fully manage all aspects of assigned projects, including but not limited to: quality decision making, stakeholder management, issues identification and resolution, and drive all aspects of project in alignment with established timelines.
This role will report to the QSIP Site Lead. The incumbent in this position is responsible for QSIP implementation at West Point. It is their responsibility to ensure that the QSIP workstreams are coordinated and implemented as intended and on time. This position supports the following types of activities: leading quality system workstream, redesign/implementation of quality system Site process, input to QSIP Lead, gap assessment and remediation of key systems. Qualifications: Education Minimum Requirement:
Required Experience and Skills:
- B.S. degree in Life Sciences or related scientific field, with a minimum of 5 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility OR
- M.S. degree in Life Sciences or related scientific field, with a minimum of 3 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality
Preferred Experience and Skills:
- • Quality Systems knowledge
- • Exposed to application of Risk Management tools and methodologies such as: FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc.
- • Ability to accurately interpret and apply regulatory expectations to the Quality Management System in a drug, device and biologics manufacturing environment.
- • Fast learner and can be a change agent
- • Technical understanding of Biologics, vaccines and small molecules business.
- • Understanding of Merck's Quality System
- • On the floor manufacturing shop experience
- Project Management, Change Execution Management and Team Leadership experience in a Quality or related 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.
- Demonstrated facilitative leadership skills and able to lead cross-functional project teams to deliver results
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
- Speaks with courage and candor.
- Strong written and verbal communication skills.
- In-depth working knowledge and application of GMPs/GLPs.
- 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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