Supervisor, Quality Assurance

SUPERVISOR, QUALITY ASSURANCE in Hopkinton, MA

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers therapies from curiosity to cure and ultimately to improve patients lives.

The Quality Assurance Supervisor is knowledgeable in industry regulations, industry best practices, and phase appropriate quality systems.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Responsibilities

• Work cross-functionally with Manufacturing, Process Development, Analytical, Facility, Engineering and Project Management on Quality Assurance (QA) activities including, but not limited to, the following:
• Review Executed/Unexecuted Batch Record
• Oversee and implement on-floor QA
• Review Executed/Unexecuted Validation/Facility Protocols/Reports
• Investigate and write documentation for Unplanned Deviations, Planned Deviations, Environmental Monitoring Excursions and Equipment Excursions
• Author, review and revise SOPs
• Review Change Controls
• Review Facility Work Orders prior to filing
• Coordinate with the QA Management and Operations to ensure disposition timelines and Quality KPIs are attained
• Coordinate with the QA Management to ensure client timelines are on schedule and attainable
• Work in coordination with QA Management to ensure QA staffs are appropriately trained and procedures are being followed
• Good understanding of contamination and segregation controls
• Be able to work on a roadmap to get from clinical to commercial Quality Systems
• Support validation activities for equipment, reviewing validation documentation and recommending methods to increase the quality of products and/or services
• Assist in assuming responsibility for the compilation of Curia documentation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations
• Participate in client audits and regulatory inspections, implement audit commitments
• Participate in client calls and/or meetings
• Train and mentor team members
• Able to develop performance metrics for the teams performance and drive improvements
• Support and mentor the team in delivering site Quality operational goals
• Lead and manage performance of the team

Qualifications

Education, experience, certification and licensures

• Bachelors degree in Life Science, microbiology, biotechnology or related field
• Minimum 5 to 8 years experience in Quality Assurance in the pharmaceutical/biotechnology or medical device industry experience, including 2 years in a leadership role

Knowledge, skills and abilities

• Excellent written and verbal presentation and communication skills
• Strong problem-solving skills, with the ability to resolve conflict
• Knowledge in FDA, cGMPs (21 CFR, 210/211, 820, and 600); ISO 9001 and 13485 a plus
• Ability to effectively present information to management and/or peers
• Comfortable working independently in combination with individuals in other departments across the organization
• Prior QC/QA experience in Biopharma/Biologics manufacturing facilities
• Supervisory experience

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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