We are an EasyHiring recruiting company that is looking for candidates for our partners for the position of Associate Director, Quality Assurance Operations in Edmonds, WA for work in Bothell , WA.

Responsibilities:

• Responsible for the Quality Assurance oversight of GMP operations at the Bothell Manufacturing site and ensuring adherence to applicable GMP regulations and BMS policies and procedures.
• Develop departmental goals and ensure the timely completion of all deliverables, including batch record review.
• Champion and foster a positive and successful quality culture, aligned with BMS’s existing culture.
• Mentor Quality personnel and enable their individual growth.
• Develop a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical controls.
• Provide direction and ensure timely guidance to Quality Operations personnel during handling and resolution of GMP events (deviations, non-conformances and corrective action assessments).
• Collaborate with stakeholders and management and communicate status to support.
• Ensure timely Quality support to site compliance activities such as Change Control impact assessments, root cause analysis during deviation investigations, and development of corresponding CAPAs.
• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management system.
• Contribute to the development and execution of Inspection readiness plan at the Bothell Manufacturing site.
• Act as subject matter expert for QA oversight of GMP operations during audits and regulatory inspections.
• 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.

Knowledge & Skills:

• Demonstrated experience building and leading exceptional teams.
• Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field.
• Experience with implementing and overseeing GMP operations in a plant manufacturing both, clinical and commercial products.
• Demonstrated excellence in written and verbal communication.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
• Experience in developing/optimizing Quality Systems related to batch records review, Quality oversight of Manufacturing operations, Deviation processes, corrective and preventative actions, strongly preferred.
• Proven commitment to quality and continuous improvement.

Basic Requirements:

• Bachelor’s degree in relevant science or engineering discipline is preferred.
• Minimum of 10 years working in a Quality within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
• Minimum of 7 years of leadership experience including multi-tiered leadership.

Preferred Requirements:

• Cell therapy experience.

Working Conditions:

• Equipment Usage During Work Period: Computer 80%; Phone and Electronic Devices 20%.
• Sitting at a computer terminal for an extended period of time.
• Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach.
• Requirement to work in a conference room / meeting environment for moderate periods of time.
• Occasional periods in labs or production area, requiring some level of gowning.
• Light to moderate lifting.
• Regular, predictable attendance is required, plus occasional overtime, as business demands dictate.
• Moderate noise i.e., business office with computers, phone, and printers.

Job Type: Full-time

Work Location: On the road