Associate Director, GMP Compliance Job

Employer
Merck
Location
West Point, PA, US
Posted
February 28 2017
Discipline
Other
Organization Type
Pharma
Associate Director, GMP Compliance-QUA005635

Description

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.


Provide compliance leadership and direction to facilities that manufacture active pharmaceutical ingredients, drug products, biologics, and vaccine products for Merck. Collaborate with site leadership to prepare facilities for successful Audits and Health Authority Inspections, to develop any resulting corrective and preventative action plans (CAPA), and to verify CAPA implementation and effectiveness. Specifically:

1. Fully understand regulatory requirements (FDA, EMA, MHRA, etc.) related to the manufacture of active pharmaceutical ingredients, drug products, biologics, and vaccine products and provide leadership and technical direction on application and implementation of these requirements.

2. Using knowledge of regulatory requirements, collaborate with site leadership to prepare facilities for Audits and Heath Authority Inspections. Provide leadership and technical direction during audits and Health Authority Inspections to ensure successful outcomes.

3. Partner with sites to identify appropriate Corrective and Preventative Action Plan (CAPA) to address any findings identified during audits and Health Authority Inspections. Monitor status of CAPA execution and closure to ensure CAPA are implemented according to plan. Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of findings. Work directly with site management to identify any additional CAPA needed to satisfy deficiencies noted during independent CAPA review.

4. Monitor and analyze the consolidated outcomes of audits and Health Authority Inspections to identify, investigate, and resolve any trends before they impact compliance and supply. Report results to Divisional and Regional Quality Councils.

5. Author policies, standards, and procedures related to Audits and Health Authority Inspections, ensuring alignment with regulatory requirements.

Qualifications

Education Minimum Requirement:

- B.S. in Life Science Field, Engineering Field or a related relevant discipline required. Advanced degree and/or MBA preferred.

Required Experience and Skills:

- A minimum of 10 years of Quality, Operational or Technical experience within the Pharmaceutical or Biotechnology Industry.

- Demonstrated ability to apply a broad knowledge of Quality Management Systems and international GMPs to the manufacture of active pharmaceutical ingredients, drug products, biologics, and vaccines.

- Will have experience (not less than 3 years) either performing Health Authority Inspections or managing Health Authority inspections and communications in a Pharmaceutical or Biotechnology company.

Preferred Experience and Skills:

- Demonstrated ability to effectively manage multiple projects/tasks simultaneously;

- Demonstrated ability to make risk based decisions;

- Demonstrated ability to influence and drive change;

- Excellent problem solving skills, based on science, facts, and data; strong demonstrated interpersonal, communication, collaboration and leadership skills;

- ability to work in a multi-cultural environment.

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:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Qual Assurance & Ops Generic

Job Title:Assoc. Dir, Quality Assurance

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Whitehouse Station, NA-US-New Jersey, NA-United States

Employee Status: Regular

Travel: Yes, 50 % of the Time

Number of Openings: 2

Shift (if applicable): 1st

Company Trade Name:Merck