Associate Director Quality Control Microbiology & Sterility Assurance
Location:
West Point , Pennsylvania
Posted:
January 20, 2017
Reference:
QUA005423
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 of Laboratory Operations is responsible for providing quality and operational direction and oversight to a team of Managers, Data Analysts and Laboratory Technicians. This individual is responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and Merck guidelines, policies and procedures. The Associate Director must be an advocate for maintaining a safe work environment. The individual in this role will be responsible for meeting customer demand including schedule adherence and right the first time execution of testing while working with their staff on employee development.

The Associate Director will lead key projects for Laboratory Operations aimed at elevating the compliance and performance of the laboratories within their responsibility. As the lead in this area the individual is expected to fully manage all aspects of assigned projects and run the business activities, including but not limited to: decision making, stakeholder management, issue identification and resolution, understanding of capacity and demand, participates and drives the tier process, as appropriate, and uses this forum to escalate concerns and best practices. Proactively partners with Laboratory Quality Assurance personnel to ensure compliance with regulations, guidelines and procedures. Ensures that all process improvements and capital projects are timely, robust and in alignment with corporate goals.


Qualifications:
Education Minimum Requirement:
  • Bachelor's degree. Degree in life science, science discipline or engineering. Degree in Microbiology, Biology or Biochemistry preferred OR M.S. degree in life science, scientific discipline or engineering.
Required Experience and Skills:
  • For candidates with a Bachelor's degree, a minimum or 5 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting.
  • For candidates with a Master's degree, a minimum or 3 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting.
Preferred Experience and Skills:
  • Progressive and demonstrated Quality decision making responsibility.
  • Project Management, Change Execution Management and Team Leadership experience in a Quality 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 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/tasks simultaneously.
  • Experience in pharmaceutical laboratory operations or related environment.
  • Previous people management experience; ability to develop staff


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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