Head of Quality

Company: Apex Systems
Location: Cambridge
Posted on: February 20, 2021

Job Description:

Head of Quality Job Scope & Purpose: The Head of Quality is responsible for strengthening, further development and execution of our client's quality assurance program and management systems, in support of all clinical development, pharmacovigilance, supply chain and manufacturing activities. He/she will direct GxP Quality related activities across the organization to support pivotal studies, global regulatory submissions (NDA/MAA, etc) and ultimately commercial launch of products. In addition, the Head of Quality will build and lead an internal team and supplement as necessary with external consultants/contractors to support QA activities, and they will provide leadership and guidance to the organization on global Quality matters. Primary Job Requirements:

• Bachelor's degree or advanced degree in related Life Sciences discipline
• 15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech or Pharmaceutical setting
• Strong understanding of US FDA and EU EMA regulations and ICH guidelines for GMP manufacturing of cell and gene therapy products
• Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials
• Experience interacting with regulatory health authorities at pre- and post-approval inspections
• Strong analytical skills and report writing skills
• Demonstrated team leadership and staff management and development experience About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT--- Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
  
  Code: RegQAEEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice

Keywords: Apex Systems, Cambridge , Head of Quality, Other , Cambridge, Massachusetts