Quality Field Supervisor - Night Shift
Specific Knowledge, Skills, Abilities, etc:
- Responsible for supervising a team of Quality Analysts to ensure cGMP compliance for site operations, including operations on the manufacturing floor, within Quality Control laboratories, and within site warehouses.
- Supervises and executes operating procedures for the site Quality Assurance program that assures real time monitoring, verification of procedural and safety compliance, executed manufacturing batch record review, and inspection readiness.
- Provides quality oversight of manufacturing, laboratory, and warehouse activities on a day-to-day basis.
- Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management complies with site and corporate procedures.
- Contributes to and supports the site team, which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
- Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.
- Hires, integrates and develops high quality talent, capable of delivering against the department's goals and objectives.
- Establish and communicates performance objectives for Quality Assurance staff that are consistent with the Quality and business unit goals.
- Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment, which enhances unit performance and integration across site departments.
Specific Knowledge, Skills, Abilities, etc:
- Knowledge of biologics Manufacturing, Drug Substance or Drug Product and batch record review is highly desirable.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge of electronic systems including any of the following: SAP, LIMS, and TrackWise is desirable.
- Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.
- Knowledge and proven experience in FDA, EMA, or other regulatory authority.
- Knowledge in Operational Excellence and Continuous Improvement is desirable.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Demonstrate appropriate examples for compliance behaviors and attitudes, thereby shaping the culture.
- Effective interaction with all contacts and the ability to work in a team based environment and interact well with other employees at various levels.
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.
- At least 8 years of experience in pharmaceuticals or biologics industry with at least 3 years in Quality Assurance or related technical function and increasing cross-functional responsibility.
- Formal training/education in quality practices is highly desired.
- Lean and/or Six Sigma certification is desirable.
- This position will require unassisted lifting of items (not to exceed 50 lbs.), bending/stooping, twisting, crouching/squatting, kneeling, sitting, walking (level surfaces), reaching (shoulder), repetitive use of arm, hands, wrists, and accurate vision (acuity, color - correction allowed). The position will require donning appropriate gowning and personal protective equipment. This position is a team-based position that will require ensuring appropriate field QA coverage is available on all shifts, including weekends, holidays, and overtime coverage when necessary.
- This position will require office-based work as well as routinely entering the laboratory, warehouse, and manufacturing floor environments to perform quality oversight activities. Workplace hazards exist including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents.
- May require up to 5% travel
- Direct supervision of Quality department employees.
- Required to provide guidance, oversee the activities, and participate in the on the job training of less experienced staff.
- Develop and grow staff to meet career and organizational development needs
- Develop and manage succession plans for team roles