Director, Quality Assurance

Company: Cambrex Corporation
Location: High Point
Posted on: February 15, 2021

Job Description:

At Cambrex, it's our people that set us apart. We work locally and have an impact globally. We're committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings! Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal - to improve the quality of life for our customers' patients across the world. Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to lead our QA team of dedicated professionals focused on customer service and quality. We are currently accepting resumes for the position of Director, Quality Assurance. Provide leadership for quality systems. Major task during GMP projects is to provide guidance and leadership in regards to quality and customer relations with GMP Operations and GMP Analytical. Responsibilities:

• Supervision of Quality Assurance staff: This function includes Performance Management activities such as promotion and performance ratings recommendation, performance appraisals writing; time/shift scheduling; overtime approval recommendation; and participation in hiring decision.
• Serve as main representative for Quality Assurance.
• Provide guidance in the development of SOPs; approve, maintain, and distribute SOPs; train and update personnel on new SOPs.
• Review and approve batch records and supporting documents.
• Perform final project release for GMP projects.
• Review and approve shipping process for GMP materials.
• Generate Quality Certificates.
• Manage efforts of staff.
• Train and develop staff.
• Review and approve change control and qualification for equipment and facility.
• Develop and review quality metric systems.
• Manage the data review system for GMP analytical testing.
• Oversee CAPA program. Infrequent Functions:
  • Support management of nonGMP facility
  • Consult with company vendors
  • Perform duties as listed for all Quality Assurance staff as needed. Requirements:
    • BS, MS or Ph.D. in Chemistry (or closely related discipline).
    • A minimum of at least 10 years of relevant background/leadership in GXP/QA/regulatory compliant pharmaceutical laboratory environment.
    • Knowledge of GMP manufacturing and analytical techniques to support QA process.
    • Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Other Desirable experience and Skills:
      • Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills.
      • Track record of successfully applying high level scientific judgment in a variety of complex and unprecedented situations.
      • Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results.
      • Ability to coach and develop staff and to transfer job knowledge and skills. Cambrex 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. Be the first to receive our latest news updates

Keywords: Cambrex Corporation, High Point , Director, Quality Assurance, Executive , High Point, North Carolina