Director, Quality Assurance

Agawam, Massachusetts, United States Full-time

Position Title: Quality Assurance Director
Job Location(s): Agawam, MA
Start Date: ASAP
Employment Type: Full Time
Starting Salary Range: Competitive
Job Requisition #: 18012

Avista Pharma Solutions is a contract testing, development and manufacturing organization (CDMO) encompassing over 200,000 square feet of laboratory and manufacturing space in the U.S. and the U.K. (Agawam, MA – Durham, NC – Longmont, CO – Edinburgh, Scotland), providing pharmaceutical, animal health and medical device clients with a broad suite of scientifically-differentiated services.

DUTIES:

  • Director of Quality will be required to be a strategic thinker as you will be responsible for the quality and compliance of the facility and maintain the data review through issuance of data and final report
  • As Director of Quality Assurance, you will be responsible for the quality metrics at Agawam, MA.
  • You will be directing the processes for internal audits, client audits and regulatory audits.
  • You will oversee the good documentation practices and data integrity to assure review and approval of Protocols, IO/PQ and Investigations.
  • You will be implementing measures and processes to ensure Agawam site is compliant to ISO 17025 and oversee registration and surveillance audits.
  • You will evaluate processes and process improvement initiatives.
  • As QA Director, you will facilitate the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to Agawam’s processes.

QUALIFICATIONS:

  • BS or BA Degree with 10+ years or MS Degree with 8+ years or equivalent.
  • Industry experience must be with Quality Assurance Systems in a contract lab environment.
  • Prior experience with strategic planning, building operations, or business operations is strongly preferred.
  • Experience managing GMP and GLP quality systems and quality policies preparation.
  • Extensive knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
  • Experience in quality systems, compliance and electronic Quality Management Systems.
  • Minimum 5 years supervisory experience.

SUCCESS FACTORS:

  • Demonstrate the capability for continued upward growth and technical contributions.
  • Exceptional analytical and problem solving skills with the proven ability to think strategically.
  • Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
  • Excellent diplomatic, analytical, and communication skills – both verbal and written.

 

Avista Pharma Solutions is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.