Director, External Quality Assurance Job - United States
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 managing a team of Quality Assurance professionals within the EQA Sterile Platform. Duties include management of compliance activities such as all Complaints, Field Alerts, Significant Deviations and Quality Council. Also provides oversight of Contract Manufacturing Organizations (CMOs) that manufacture, test, packaging, storage, and distribute sterile pharmaceutical products.
Assures products are produced from approved processes conforming to all applicable regulatory requirements and Company policies and may include the release of all manufactured products Ensures the quality performance of CMOs through direct oversight, support and technical advice. Scope of responsibilities includes ensuring adherence to all Merck and Agency GMP Quality Systems expectations; systems include, but are not limited to, Change Control, Complaints, and Deviation Management.
Responsibilities also include oversight of Annual Product Reviews, ensuring Field Alert Reports are submitted on time and accurately to FDA, tracking and trending of departmental performance via the Site Quality Council. Strong demonstrated leadership skills are a must to build and retain talent in the organization via coaching, teaching, mentorship and purposeful succession planning.
Education Minimum Requirement:
- BS in Science related field, including engineering.
Required Experience and Skills:
- Minimum of 10 years Industry experience.
- Previous or current supervisory / management experience.
- Previous experience in Sterile Manufacturing, (in either Tech Ops, Mfg or Quality), people management, Regulatory Inspections, and in managing significant investigations is required.
Preferred Experience and Skills:
- Excellent presentation, written and verbal communication skills.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Regulatory Compliance
Job Title:Dir, Quality Systems & Compliance
Primary Location: NA-US-PA-West Point
Other Locations: NA-United States, NA-US-NC-Durham
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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