This position is expected to be the Quality Lead for the Biological Process Sciences (BPS) organization which includes locations in St. Louis, MO and Princeton, NJ. As a leader for the group, this individual will exhibit leadership traits and characteristics and be perceived by not only his/her group as a leader, but also by the site personnel when Quality issues arise around the St. Louis, MO and/or Princeton, NJ sites related to BPS activities..
* Oversees, manages, and ensures the successful day-to-day operations of the department
* Understanding of Quality in a Biologics development Space
* Sets goals and objectives for the department in alignment with the Sr. Director of Quality and the BPS functional area
* Ensuring safety message is implemented and lived throughout their organization and bolster this throughout the facility as possible
* Ensuring the functional areas within BPS successfully execute all program support activities and cell banking manufacturing within phase appropriate quality requirements for manufacturing and development activities in accordance with specified timelines.
* Ensure the timely review of records, SOPs, analytical documents, reports, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements for all BPS activities
* Establish meaningful goals and metrics for groups in conjunction with the Senior Director of Quality and manage the performance of the team to those goals.
The Sr. Manager of Quality will also interface with customers to ensure clear and open communication is maintained when intermediate levels of escalation are required. The Sr. Manager of Quality will also be required to ensure quality and compliance are maintained in the face of customer challenges to internal decision making, and to be able to effectively communicate and work with customers to resolve any disagreements that arise in this regard.
Coaching and mentoring to direct reports will be required on a regular basis.
*REPORTING RELATIONSHIPS: *Typically, directly manages 3-5 employees located at the St. Louis, MO and Princeton, NJ sites.
*ESSENTIAL JOB FUNCTIONS:*
* Ensuring all BPS activities are compliant with the Phase appropriate quality oversight practices of the company
* Communicating priorities and distributing work assignments to direct reports. Ensuring that all work performed by staff is performed safely, with quality, and in a timely, compliant manner.
* Leading and ensuring the group is participating in continuous improvement projects throughout the group and the facility/operational portions of the organization. This includes all Quality systems and processes.
* Leading, managing and/or participating in the BPS Leadership team meetings and providing guidance and input relative to strategic plans.
Ensuring adequate training (skills-based, cGMP and Safety) of associates within department.
Experience and Skills:
*EDUCATION AND QUALIFICATIONS:*
* Bachelor's Degree in Life Sciences or Chemical/Biochemical engineering.