Supervisor, QC Analytical – Allendale, NJ

Our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

This position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. The Supervisor, QC Analytical will lead Quality staff members across various shifts.

Essential Functions and Responsibilities:

• Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
• Schedules and monitors daily operation of department based on projected client demands.
• Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
• Approval of investigations and documentation of non-confirming events and OOS.
• Recommends process improvements to achieve greater efficiency within the department and between sites.
• Participates in department and cross functional meetings.
• Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
• Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree in Science or relevant field; Minimum of 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent.
• Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
• Strong knowledge of analytical test methods and philosophies.
• Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
• Proficient with computer software with MS Office and LIMS

Competencies/candidate profile:

• Acts decisively
• Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively.
• Builds and maintains relationships
• Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders.
• Communicates effectively
• Fosters continuous improvement and innovation
• Fosters integrity and honesty
• Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.
• Manages projects and functions

Supervisory Responsibilities:

• Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.
• Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.
• Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.
• Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
• Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
• Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
• Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.