Associate Director West Point Quality Assurance
Location:
West Point , Pennsylvania
Posted:
February 03, 2017
Reference:
QUA005283
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 Focused Factory 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 may lead a team of individuals. People Managers support the development of personnel through effective coaching and feedback and by modeling inclusive behaviors.

The Associate Director may 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 may be primarily responsible for support of one of the following:

- Automation Compliance team - This team is responsible for change control approvals of automation systems, SAP and MES. In addition, the Lead will help support enhancements to the Site Data Integrity procedures and processes. The role will require the oversight of ~6 direct reports.
- Change Control team - This team is the primary quality contact for change control administration at the site. In addition, the Lead will help support enhancements Quality System Improvement Program (QSIP) and help to integrate all change control into a single focused Quality Assurance function. The role will require the oversight of ~8 direct reports.
- Supplier Management/Annual Product Report team - This team is tasked with completion of the APRs, Quality Agreements, Business Continuation Memos and various other Supplier Oversight functions for the West Point Site. The role will require the oversight of ~7 direct reports.

Each of these roles will also be key in advancing inspection readiness across QMS and may play a key role in inspection execution as a team lead and individual contributor.


Qualifications:
Education Minimum Requirement:
  • • 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
Required Experience and Skills:
  • Minimum 4 years managing personnel.
  • Quality Systems knowledge

Preferred Experience and Skills:

  • Exposed to application of Risk Management tools and methodologies such as: FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc.
  • 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 staffingaadar@merck.com.

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:

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