Associate Director - Quality Assurance (GCP/GLP)
Location: Greater Boston, MA (Onsite)
Science/ Focus: Biologics
Job Overview: Our client is looking to add an Associate Director of Quality Systems to support and expand on the quality management systems and processes and be a key stake holder in driving the quality culture including GCP and GLP compliance.
Primary Job Responsibilities:
- Oversee the development and implementation of Quality systems including CAPA, deviation, risk analysis and change control management.
- Perform inspections and internal audits and participate in audit preparation
- Oversee qualification of equipment, systems, and suppliers
- Create, revise employee training and review SOP’s and work instructions
- Oversee qualification of equipment, systems, and suppliers
- BS with 5+ years in biopharma Quality Assurance (Extensive experience within GLP or GCP preferred)
- Strong experience in Quality Systems- CAPA, deviation, risk analysis and change control management
- Experience preparing for and participating in FDA inspections is highly preferred
- Experience driving the certification procedures for CLIA/ CAP is a plus
- Previous team leadership experience is highly preferred
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.
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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.
EEO 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 employeeservices@apexsystems.com or 844-463-6178.