Sr Supervisor, Quality Assurance

Biogen SANDBOX•Research Triangle Park, NC

13d

About The Position

The Quality Assurance Sr. Supervisor is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within QA at the Biogen Research Triangle Park (RTP) facility.

Requirements

Minimum 5 years technical and supervisory experience in a regulated environment.
Advanced understanding of Quality concepts; able to practice and implement them
Ability to develop innovative/creative solutions to complex problems
Investigative

Responsibilities

Direction and development of the QA department with regard to personnel and QA functions.
Coordinate and evaluate employees
Perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resource policies and procedures.
Evaluation, scheduling, and balancing of departmental workload with respect to assignments/responsibilities/personnel
Management of projects
Adherence to all regulatory licenses and regulations
Interfacing with key Quality and Manufacturing customers.
Support the QA Manager/Sr. Manager for activities related to interviewing, hiring and training of employees, compliance with training policies, performance evaluations, and supporting resolution of employee-related issues.
Recommend changes to existing Quality systems and GMP processes (change control), identify gaps in existing Quality systems, propose solutions to QA management and perform job functions of the QA Manager/Sr. Manager as delegated.
Assessment of batch acceptance and final batch disposition decision for clinical and commercial production batches and final QA approval of major/critical planned exceptions or deviations.
Support Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required.
Supervise quality management projects including the oversight of team members as assigned.
Ensure Product Disposition documentation and other documents supporting batch disposition are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
Direct, lead, coordinate, and support the activities of QA personnel to ensure that all activities are focused upon high productivity and the utmost technical integrity.
Provides mentorship and training within and across functions.
Oversee and lead the QA team to provide quality/compliance support and expert guidance to manufacturing operations.
Assist QA Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.