Quality Assurance Supervisor, Quality Release - Planet Pharma : Job Details

The position will help to represent the Quality organization in the oversight and monitoring of GMP release activities, including finished drug product. The position will be a key point of contact for communications between manufacturing and Quality, with the goal of optimizing informed decision making. The position will be fluent in release processes and procedures.

Shift: Monday to Friday 3:00pm - 11:30pm.

Essential Functions and Responsibilities

Supervision and Development direct reports, mentoring/coaching to motivate and mentor peers/staff to foster a culture of continuous improvement, quality, and excellence.

Perform real-time support for escalations to ensure compliance with GMP and GDP quality initiatives.

Ensure appropriate and timely escalation of significant quality issues

Schedule and coordinate daily activities related to final drug product release, disposition, and lot closure ensuring conformance to the daily schedule and overall site compliance.

Support raw material, component, and kit release as required.

Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements.

Support final product drug label issuance and reconciliation

Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.

Drive continuous improvements to systems, policies, procedures, and ways of working to create a more efficient release process that is agile, nimble, compliant, and meets the needs of the business to serve autologous cell therapy patients.

Review of Quality System records for compliance.

Must adhere to the core values, policies, procedures, and business ethics.

Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

Perform miscellaneous duties as assigned.

Provide support for audits as required

Track data for Quality Release metrics as required

Other duties as assigned

Required Education, Skills, and Knowledge

Minimum B.S. in biology, biochemistry, bioengineering, related technical field, or equivalent industry and technical experience.

Minimum of 5 years of experience in biopharmaceutical-based GMP cell therapy or bioloigcs industry. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired.

Quality release experience required.

Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals; 21 CFR 1271 is a plus

Excellent oral and written communication skills

Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner

Must be comfortable in a fast-paced environment and changing priorities

Experience with use of an electronic QMS, MasterControl

This role is on-site and shift based.