Overview
The KOP Site QA Head role is responsible for providing Quality leadership and ongoing site-based Quality Assurance support to the WuXi Biologics, King of Prussia (KOP) site, a biopharmaceutical development lab. This role is expected to manage and continuously improve the quality systems and resolve routine quality issues related to product development and testing activities in the Upstream/Downstream Process Development and Analytical Science departments, as well as supporting operational and EHS activities with facility/utility/equipment.
Responsibilities
- Continue to improve site quality systems. Connect with WuXi Global QA and other PD site QA for Quality guidance and communication.
- Interface collaboratively with other functions and stakeholders. Represents QA on various internal teams and meetings with client.
- Negotiate and collaborate with client for establishment and lifecycle managmenet of quality memo/agreement.
- Communicate with client for atypical events within specified timeframe per quality memo.
- Host client quality visit.
- Provide training for internal quality processes and client quality memo.
- Routine management & coordination of compliance activities, especially for data integrity.
- Uses established QA procedures and methodologies, exercises judgment to propose solutions for straight forward problems under limited guidance/coaching. Escalate critical to quality issues to sr. management in a timely manner.
- Conduct QA internal audit and walkthrough. Identify compliance risks.
- Review atypical event report, monitor the implementation of corrective actions for any atypical event, ensure proper closure of corrective action with effectiveness check, and document for traceability in Quality System.
- Participate tech transfer process, review and approve protocols and reports.
- Maintain site quality metrics and report to line manager periodically for QS performance review.
- Supervise direct report (QA specialist). Provide coaching and mentoring for personnel development, to enable growth and retention.
Qualifications
- BS degree in chemistry, biology, microbiology, bioengineering or other related scientific discipline, advanced degree preferred.
- At least 10 years relevant experience in biotech and/or pharmaceutical environments, of which minimum of 5 years’ experience in a QA role, for executing, developing, and/or managing quality programs.
- Strong working knowledge of audit, deviation investigation, CAPA, and data integrity. Result orientation and attention to details.
- Experience with computer system validation highly desired.
- Experience as a people manager desireable.
- Experience as lab technical role is a plus.
- Excellent interpersonal skills. Able to communicate well with stakeholders, both orally and in writing to promote site quality culture.
- Excellent presentation skills. Able to present site Quality status to sr. management and client.
- Familiar with MS Office tools such as Word, Excel, PowerPoint, MS Project, and Visio.
- Demonstrated ability to work as a team player with multi-disciplinary project teams.
- Quick learner and decision maker, able to make decision with sound quality justification.
- Ability to adapt to, and embrace fast-paced and changing conditions. Strong sense of urgency to maintain project deadlines is required.
