Bristol Myers Squibb Company

Supervisor, QA Operations

Location
Bothell, WA, United States
Posted
Aug 28, 2020
Ref
R1527727
Required Education
Masters Degree/MBA
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

This is a Wed - Sat AM Shift 6a - 4:30p

PURPOSE AND SCOPE OF POSITION:

The QA Shift Supervisor is responsible for leading a team that provides QA oversight of GMP operations including batch record review production and associated cGMP records to assure product quality is consistent with established standards and in compliance with regulatory and industry standards.

In addition, the Supervisor will be responsible for the people involved in the day to day Quality Assurance Operations associated with the production of both clinical and commercial autologous cell therapy product. This person will be a key leader responsible for GMP operations and meeting critical business goals.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:
  • Master's degree in related field is preferred. Minimum of Bachelor's degree is required.


Experience
  • 7+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
  • Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.


Knowledge, Skills, and Abilities
  • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.
  • Proven commitment to quality and continuous improvement.
  • Possesses excellent compliance understanding. This includes both technical and regulatory requirements pertaining to equipment function and application. Understands biotechnology processing, the purpose of unit operations, clean room design and behavior, and microbial control concepts, including aseptic technique. Is able to couple a technical process understanding with a strong regulatory and compliance understanding to ensure that operations are conducted in an efficient, and above all, compliant manner to deliver safe and effective therapies to our patients.


DUTIES AND RESPONSIBILITIES:

Key Responsibilities
  • Using the production schedule, develops and manages a daily plan for a work team of Quality Assurance Operations associates.
  • Leads/ supports deviation process, investigations and closure. Participates in cross functional project teams, provides QA support to technical transfers in conjunction with relevant teams/ individuals.
  • Ensures deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner.
  • Ensures QA reviews and approves documents, including standard operating procedures, batch records, material specifications, and validation protocols and reports.
  • Interviews, hires, coaches, motivates, and develops exceptional staff. Sets performance objectives and development plans. Monitors performance progress conducts annual performance reviews for all direct reports and recommends advancements for Quality Assurance Operations Team when appropriate.
  • Champions a culture of exceptional teamwork, communication, and continuous improvement within the QA Operations team and across the organization.
  • Ensures a culture that embraces the safety of the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
  • Identifies and mitigates risks in production, quality and supporting operations that could negatively impact the safety, identity, strength purity or quality of the product.
  • Assists in the design, implementation and continuous improvement of Quality Assurance systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
  • Provides leadership support during trouble shooting of equipment, operation and processes as it relates to ensuring the quality and compliance of the product.
  • Provides Quality input during the optimization of the use of raw materials, equipment and personnel in producing compliant products and leads/participates in continuous improvement initiatives as part of Juno's commitment to operational excellence.
  • Assists in the development and communication of team policies, organizational structure, shift structure, and career ladders. Ensures adherence to all policies and regulations.
  • Actively pursues learning of required skills and new skills.
  • Ensures team goals are met.


WORKING CONDITIONS (US Only):
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
  • Work in areas that may have strong magnets.
  • May work in areas with exposure to vapor phase liquid nitrogen
  • Must be able to obtain gowning qualification to enter a cleanroom environment
  • May be required to work nights, weekends and holidays in a 10-hour shift structure.
  • Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.


This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.