Quality Systems Specialist 2051218
: Job Details :

Location: Cambridge MA (Hybrid)

Therapeutic Area: Rare Disease

Job Overview: The Senior Specialist of Quality Systems and Compliance focuses on improving and maintaining quality management systems, ensuring compliance, and supporting audit and inspection readiness.

Primary Job Responsibilities:

• Oversee daily QA compliance aligned with company policies.
• Enhance QMS through validation and data process improvements.
• Manage deviation resolutions and CAPA processes efficiently.
• Maintain readiness for audits, ensuring regulatory compliance

Primary Job Requirements:

• BS/BA in Life Sciences with over 5 years in biotech/pharma industries, proficient in Veeva Systems QMS Modules.
• Expert in FDA/EMA regulations, adept in GxP compliance, and experienced in quality oversight of manufacturing operations.
• Skilled in managing deviations, CAPA, and change control, ensuring regulatory compliance within deadlines.
• Strong organizational and analytical skills, excels in technical writing and communication across levels.
• Lead quality compliance education, foster a quality-focused culture, and can adapt to a dynamic biotech environment.

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.