We are a recruiting company EasyHiring, which is looking for candidates for our partners for a position Associate Director, Quality Assurance Operations in Bothell West, WA for work in Bothell, WA

The Quality Assurance (QA) Associate Director (AD) will be responsible for leading multiple shifts and two sites (Bothell and Seattle), who are involved in the daily activities of manufacturing, assessing and releasing drug products at the Bothell site, and providing quality oversight of Viral Vector Determination Team at Seattle (Dexter). The primary focus of the AD of QA Operations Shop Floor will be to provide quality oversight of GMP operations and ensure compliance with all relevant quality standards and regulations throughout the product lifecycle, from product receipt to release.

The QA AD will also be responsible for overseeing QA activities, ensuring that batch records are reviewed promptly, and that the Quality Management System is effectively implemented, including Quality review and approval of document changes, deviations, change control assessments, and Quality risk management assessments.

The QA AD has a strong understanding of GMP (Good Manufacturing Practices), SOPs (Standard Operating Procedures), and regulatory requirements, as well as proven experience in quality assurance in a pharmaceutical manufacturing environment. QA AD should have excellent communication and interpersonal skills, be a strong leader and able to work collaboratively with cross-functional teams to achieve common goals.

Overall, the QA AD will play a key role in ensuring the continued success and growth of Bothell and Dexter facilities, maintaining the highest standards of quality and compliance, and supporting the development and manufacture of drug products.

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 BMS 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.

orking 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.

The starting compensation for this job is a range from $149,000 - $188,000​, plus incentive cash and stock opportunities (based on eligibility).

Job Type: Full-time

Work Location: On the road