Manager Quality Systems

Waltham, MA

QA Manager, Quality Systems 1132506

Job Scope & Purpose:

Our biotech client is looking for QA Manager in their Quality Systems team. The individual in this role will work closely with QA colleagues responsible for quality operations to provide support for internal and external stakeholders related to GMP operations. The Manager of Quality Systems is responsible for the implementation, and oversight of investigations, CAPAs, product complaints, and change controls.

Primary Job Responsibilities:

  • Plan, support, and manage continuous improvement projects in support of events, CAPAs, change control, product complaints, etc.
  • Provide support and leadership for eQMS scope definition, planning, communication, design, and implementation
  • Conduct QA reviews in support of events/investigations, CAPAs, product complaints, and change controls
  • Support training of functional areas and development of appropriate training for personnel involved in the execution of Quality System processes
  • Coordinate and generate quality metrics in support of periodic Quality Management Review and initiatives to drive for continuous improvements
  • Promote a Quality Culture by supporting innovation, teamwork and efficiency within the organization
  • Support regulatory inspection readiness activities
  •  Develop and implement standards, policies, and procedures for GxP regulatory compliance

Primary Job Requirements:

  • Minimum of 5 years of relevant Quality experience in drug and/or biologics within the pharmaceutical or biotechnology industry, including early and late-stage development
  • Demonstrated experience in the development, implementation, and assessment of quality/compliance programs for GxPs, FDA, EMA regulations, guidance
  • Microsoft Office and Veeva Vault Quality Suite experience is preferred
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations

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.

jditalia@stratacuity.com

Code: TechOps

 

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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@apexsystemsinc.com or 844-463-6178.