Supervisor, Quality Control

Lonza•Houston, TX

3d•Onsite

About The Position

The purpose of this role is responsible for leading a team of record investigators to ensure accurate, succinct and timely completion of investigations. The position will coordinate and monitor direct report’s workload and provide support commensurate to experience level. Assisting in team member growth through mentoring and trainings aimed at increasing performance, quality of work and productivity. Supervisors are able to coordinate multiple departments and cross functional activities through strong meeting facilitation, conflict resolution, real-time troubleshooting, and prompt decision making.

Requirements

Advanced skills in spreadsheet creation, record keeping, and planning.
Must have strong organizational skills with ability to manage and prioritize multiple assignments synchronously.
In-depth knowledge of cGMP principles.
Able to identify breach of cGMP principles and provide suggested corrective actions.
Is developing Subject Matter Expertise and is recognized as a source of reliable information.
Uses knowledge of defined SOPs & policies to make decisions.
Bachelor’s degree in biology or other life sciences, with 3-5+ years’ cGMP, QC/QA experience.

Nice To Haves

Prior experience with SAP and TrackWise a plus.

Responsibilities

Ability to lead and direct the daily activities required of the deviation investigation group to ensure high quality and compliant investigations are completed in a timely manner per standard timelines; ensure appropriate actions and escalations are being identified, and issues are resolved quickly and effectively.
Data driven, strategic leadership to ensure targeted team performance to achieve expected business results.
Resource planning and projections, identification of departmental areas of development and assignment of specific actions in alignment with metrics to increase group performance and productivity.
Complex conflict resolution and problem solving in cross functional setting, ability to provide direction where needed.
Demonstrates ability to coordinate multiple departments and cross functional activities through strong meeting facilitation, conflict resolution, real-time troubleshooting, and prompt decision making.
Demonstrates ability of conducting performance reviews, setting department performance goals alongside Department Manager and Director, completion of departmental metrics, and maintaining positive working relationships with customers.
Mentor, coach, train, and develop employees through 1:1 meetings, support recruiting, staffing, hiring, onboarding performance management, promotion and discipline of deviation investigators as appropriate.
Capability to lead and train a team of deviation investigators Levels I to IV ensuring accurate, succinct and timely completion of investigations, mentoring and developing the team through trainings aimed at increasing performance, quality of work and productivity.
Expected to demonstrate expertise in project management, be technical experts on deviation investigations, and have an in-depth understanding of the manufacturing process so that guidance and direction for quality investigations and overall site deviation reduction is achieved.