GMP Supervisor - Fremont, CA | ug2 | San Francisco Bay Area

UG2 is seeking an experienced GMP Supervisor to lead GMP cleaning operations on one of our life sciences accounts. In this role, you will direct day-to-day activities and ensure the highest standards of cleanliness, documentation, and regulatory compliance. The ideal candidate is a hands-on leader with a proven GMP background who thrives in a highly regulated environment, provides clear and confident direction, and coaches technicians to perform to the highest standard.

POSITION SUMMARY:
The GMP Supervisor is accountable for shift readiness, execution, and same-shift verification of GMP cleaning activities. Responsibilities include leading the shift huddle, directing technicians, verifying adherence to SOP sequence and documentation requirements, escalating deviations without delay, and training and coaching personnel to ensure they are qualified before assignment. This role operates within the applicable GxP regulatory frameworks, including GMP (21 CFR Parts 210/211) and 21 CFR Part 11.

KEY RESPONSABILITIES:

Shift Readiness & Planning

* Confirm daily attendance, task assignments, and personnel readiness prior to each shift.

* Validate shift feasibility, personnel readiness, materials, equipment, and room access, and report any conflicts before work is released.

* Coordinate with the Site Manager and client stakeholders to confirm shift feasibility, room availability, and staffing.

Execution & SOP Oversight

* Lead the shift huddle, assign rooms and tasks, and confirm team understanding.

* Conduct pre-task readiness checks, direct technicians, and verify adherence to SOP sequence.

* Verify the use of fresh solutions, dedicated tools, and proper preparation prior to use.

* Implement shift actions and communicate progress to leadership.

Quality, Documentation & Completion

* Review completed work, perform final visual inspections, and conduct same-shift completion reviews.

* Verify same shift e-Log completion, accuracy, and attributable corrections.

* Provide records and correct field documentation as required.

* Initiate and follow up on work orders, confirm FDP documentation, and report exceptions.

Deviations & Escalation

* Stop and contain work as appropriate, document the event, contact support, and escalate immediately.

* Hold work and follow approved direction until the issue is resolved.

Communication & Customer Requests

* Communicate requests, assign qualified personnel, confirm access and materials, verify execution, and provide updates to Site Manager.

* Provide shift facts, completion of evidence, and field-impact input.

* Validate field data and identify practical opportunities for improvement.

* Report urgent matters to the client promptly.

* Coordinate communication with the client on all open items and as needed.

* Prepare and deliver weekly and monthly reports to the client.

Training & Competency

* Deliver or coordinate task training and coach personnel.

* Verify demonstrated competency and confirm readiness before work assignment.

* Establish, track, and verify role-based GxP and GMP training compliance for all facility staff.

Quality Management System (QMS) Oversight

* Manage day-to-day QMS operations, including document control, change controls, and product quality reviews.

Deviation & CAPA Management

* Lead root-cause analysis (RCA) for quality events and failures.

* Implement of robust Corrective and Preventive Actions (CAPAs).

Audit & Inspection Readiness

* Serve as the primary liaison or host for regulatory inspections (e.g., FDA, EMA).

* Lead investigations for internal and external vendor audits.

Validation & Qualification

* Oversee or partner with engineering to ensure Computer System Validation (CSV), equipment qualification (IQ/OQ/PQ), and process and cleaning validation meet strict standards.

QUALIFICATIONS:

* Minimum of 3 years of GMP experience in a pharmaceutical, laboratory, or other regulated manufacturing environment.

* Minimum of 1 year of lead or supervisory experience directing technicians.

* Working knowledge of SOPs, eLog or electronic documentation, and Good Documentation Practices.

* Knowledge of GMP, OSHA, and workplace safety requirements.

* English proficiency in both speaking and writing.

* Working knowledge of applicable GxP regulations, such as 21 CFR Part 11 (electronic records), 21 CFR Parts 210/211 (pharmaceutical GMP), and EudraLex Volume 4 / Annex 1 where applicable.

* Expertise in ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate).

Knowledge, Skills & Abilities:

* Strong leadership, coaching, and team development skills.

* Attention to detail with a commitment to documentation accuracy.

* Strong communication and problem-solving skills.

* Sound judgment in stopping work and escalating deviations.

* Proficiency with Microsoft Office and work order or facility management systems.

* Ability to cultivate a quality culture, championing compliance as an organizational value rather than a check-the-box exercise.

* Cross-functional negotiation skills to resolve friction points objectively, such as production timelines versus quality holds.

About UG2

Founded in 2012, UG2 is privately held and headquartered in Boston, Massachusetts. At UG2, we set the standard in facility services through our relentless pursuit of innovation and excellence. We take pride in exceeding client expectations and fostering a culture of continuous improvement.

GMP Supervisor - Fremont, CA

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