Director, Quality in Burlington, MA at AMRI

Date Posted: 8/19/2019

Job Snapshot

Job Description

Director, Quality in Burlington, MA

 

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Director, Quality is responsible for leading the quality program including quality assurance, QC analytical and QC microbiology at AMRI Burlington site. Constantly bring new developments in analytical and microbiological sciences, regulations and industry best practices to AMRI quality program. 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 will be a key change agent while supporting a culture of safety.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities

 

  • 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 at the site
  • 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 through a structural process of objective setting, performance appraisal, and individual development as appropriate. By improving individual performance and group collaboration, the Director will be responsible  for improving the overall department productivity  and  efficiency
  • Oversee the Document Control (e.g., Change Control, Deviations, CAPA, Complaints), Training, and Internal Audit functions for the site
  • Facilitate generation of Annual Product Review (APR) documentation for customers
  • Oversee and responsible for the quality program enabling the aseptic services. This includes overseeing and assisting with the training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification  reports,  analytical reports, and manufacturing records
  • Responsible for the release or rejection of GMP materials and products
  • Prepare, review, and approve external and internal response(s) and other documentation required by regulatory  agencies, customers, or to support the quality assurance function
  • Act as company's representative 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 as needed. Ensure AMRI maintains an Approved Supplier List
  • Exhibit and promote safety awareness and safe work practices at all times

Job Requirements

Requirements

•         Bachelor’s degree in Microbiology, Chemistry, or related field required; advanced degree preferred

•         10 years QA experience in drug product environment; minimum 5 years experience in Aseptic manufacturing/ GMP laboratory. 

•         Prior managerial responsibilities required

  • Demonstrated leadership experience in including organization development and organizational planning of Quality Assurance teams. This includes promoting a culture of strong development planning, succession planning, and leading organizational change
  • Ability to define, build, and implement a robust quality system, consistent with regulatory expectations while embracing operational excellence
  • Provide strategic guidance to the AMRI Burlington site; ability to align site objectives with the corporate vision
  • Superior influential and negotiation and communication skills; ability to interface with clients during business development activities an audits
  • Solid knowledge in FDA, EMA, and ICH regulations; particularly in aseptic manufacturing

All interested applicants must apply online.  AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness.  Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.



Shift:  Standard 8

Albany Molecular Research, Inc. 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-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.

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.