Quality Assurance Manager
Absorption

Exton, Pennsylvania

Posted in Pharmaceuticals


This job has expired.

Job Info


Absorption Systems, a preclinical Contract Research Organization located in Exton, Pennsylvania, is seeking a candidate for a Quality Assurance Manager to add to our growing organization. The Quality Assurance Manager is responsible for providing leadership to a team of Quality professionals and to serve as the primary Quality resource in support of GMP and GLP Quality systems.

Responsibilities:

  • Serve as the primary Quality resource and provide strong leadership in support of GMP and GLP Quality systems, such as Investigations, Change Control, Out-of-Specifications, CAPA, Raw Materials, Risk Assessment and Training
  • Identify, resolve and report Quality issues and drive continuous improvement actions
  • Effectively manage and mentor Quality staff to emphasize positional responsibility, personnel development and succession planning throughout the unit.
  • Mentor Quality personnel in the necessary skills to review and approve highly technical documentation.
  • Provide direct oversight of activities related to participation in Regulatory Agency inspections and client audits
  • Develop and drive continual GMP and GLP Quality standards
  • Track Quality Metrics and provide feedback and results to executive staff regarding key Quality related initiatives of continuous improvement, ensuring best practices
  • Oversee the Controlled Substances program: maintain registration, conduct internal audits, host DEA inspections and coordinate response with affected parties
  • Review and negotiate client Quality Agreements
  • Oversee the performance of internal audits and supplier audits
  • Participate in interdepartmental/site leadership and operational excellence initiatives.
  • Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site.
  • Maintain the facility in an inspection ready state for Regulatory Agency inspections and client audits
  • Enforce and ensure compliance with Standard Operating Procedures
  • Proactively identify initiatives of continuous improvement, ensuring best practices
  • Support management needs in other related duties, as required

Required Education/Experience:
  • Minimum ten years' experience working within the pharmaceutical or biotechnology industry, in a GLP/GMP environment in a Quality Assurance management role
  • A Bachelor's degree in a scientific field
  • Experience in Regulatory Inspection participation is required
  • Attention to detail
  • Excellent communication and interpersonal skills
  • Excellent organizational skills

Local Candidates Preferred

Benefits

Absorption Systems cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a comprehensive benefits package that meets their personal needs.

About Absorption Systems, a Pharmaron Company

Absorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. Additionally, Absorption Systems goes deep into each of those areas, offering in vitro, in situ and in vivo models to assess the properties in question. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. Absorption Systems has facilities in Exton, PA, San Diego, CA, and Boston, MA to serve customers throughout the world.

Alongside of our enthusiasm for science and research, we have a passion to see each and every one of our employees grow and succeed both personally and professionally. We encourage our employees to continually enhance their ability to contribute to the success of the organization and advance their careers. Absorption Systems is committed to creating an environment where individuals are encouraged to grow and work in collaboration with each other while being passionate about innovation. The professional culture of our organization is a goal oriented environment full of internally driven and motivated professionals. Our company is unique in the fact that there is freedom for autonomy to execute and the ability for each employee to grow in directions that align their individual aspirations with company growth.

Absorption Systems is proud to be an Equal Employment Opportunity and Affirmative Action employer.


This job has expired.

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