Head of Quality, ABQ in Albuquerque, NM at AMRI

Date Posted: 1/26/2020

Job Snapshot

Job Description

The Head of Quality, ABQ is responsible for leading the quality program including Quality Assurance, Validation, QA Compliance, and QC Analytical and Microbiology Laboratories at the AMRI Albuquerque site; Evaluating and implementing new developments in sterile manufacturing, analytical and microbiological sciences, regulations and industry best practices; Establishing and maintaining a risk-based and scientific-based quality system to protect the public health and to meet AMRI's business needs. The Director of Quality will be a member of the site leadership team, operating cross-functionally, and supporting a culture of safety.

Position Responsibilities
Other duties may be assigned

  • Establish and maintain a risk-based and scientific-based quality system to protect the public health and to meet AMRI's business needs.

  • Through a quality system approach, ensure all GMP operations are in compliance with appropriate quality oversight, while maintaining an efficient workflow.

  • Establish and maintain an efficient and compliant validation program including process validation, cleaning validation, computer software validation, analytical method validation, and instrument qualification.

  • Provide leadership and management within the department and site through a structural process of training, objective setting, performance appraisal, and continual improvement.

  • Responsible for the site release or rejection of GMP materials and products.

  • Oversee the Document Control, Quality Events (e.g., Change Control, Deviations, CAPA, and Complaints), Training, and Internal Audit functions for the site.

  • Facilitate generation of Annual Product Review (APR) documentation for customers.

  • Coordinate and approve external and internal response(s) and other documentation • required by regulatory agencies, customers, or to support the quality assurance function.

  • Serve as the primary Quality contact during regulatory agency and customer inspections.

  • Ensure site has a robust supplier qualification program through auditing of vendors and outside contract organizations. Maintain Quality Agreements and Approved Supplier List, as needed.

Job Requirements

Education: Bachelor’s degree in Microbiology, Chemistry, or related field required or equivalent experience; advanced degree preferred

 

Relevant Work Experience:  10-15 years QA experience in a GMP drug product environment; minimum 5 years of experience in aseptic manufacturing.  Prior managerial responsibilities required.

 

Knowledge, Skills & Abilities:

  • Demonstrated leadership experience in promoting a culture of organization development and change, succession planning, and operational excellence.

  • Ability to define, build, and implement a robust quality system, consistent with regulatory expectations.

  • Provide strategic guidance to the AMRI Albuquerque site, and to align site objectives with the corporate vision.

  • Superior influence, negotiation, and communication skills.

  • Demonstrated ability to interface with customers during deviation resolution, business development activities, and audits.

  • Solid knowledge in FDA, EMA, and ICH regulations, particularly in the aseptic manufacturing space.


Shift:  First Shift

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

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AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.