Juno, a Celgene Company, is seeking a Director, Quality IT and Data Integrity. This position will provide Quality Assurance oversight of electronic data systems used in support of GMP operations throughout their lifecycle at our manufacturing facility in Bothell, WA. In addition, in collaborative partnership with IT and Validation, this role is responsible for identifying, proposing, defining user requirements and implementing integrated electronic data systems that improve the effectiveness, efficiency, and cGMP compliant Data Integrity in a cGMP facility. This includes electronic spreadsheets, laboratory and manufacturing data acquisition systems and IT controlled manufacturing equipment. This role is also responsible for promoting and fostering an operational excellence culture within the manufacturing facility, trending of compliance and operational key performance indicators (KPIs) for site IT and Data Integrity initiatives, identifying and driving continuous improvement to ensure the Quality Unit adequately fulfills its regulatory compliance responsibility and ensuring patient safety in a most productive and efficient operational model.
- Review and approve policies, procedures, validation documentation for e-systems used across the cGMP manufacturing and laboratory operations. Serve as the site DI subject matter expert (SME) and promote/train/coach site staff on ALCOA principles and associate worldwide regulations.
- Ensure the validation, implementation and change management of e-systems used across the site operations are conducted in compliance with applicable regulatory requirements (FDA, EMA, etc)
- Act as business/process owner for the implementation of technology solutions for processes used across the Quality Control and Facility operations including QMS, LIMS, LMS, equipment-LIMS interfacing, testing/liquid handling automation system, manufacturing control systems and data acquisition systems.
- Effectively partner with IT, Validation and other key stakeholders to ensure a compliant management of the e-systems lifecycle.
- Automate data gathering, processing and information management in support of Quality compliance and operational KPIs trending; issue periodic trending reports.
- Drive continuous improvement to enhance productivity and efficiency of operations across the manufacturing site.
- Work closely with site support departments such as OE, Manufacturing Compliance, MSAT, to develop in-house expertise with Lean process improvement and promoting a Lean culture.
- Support other Quality functions with resource modeling in support of commercial inspection readiness.
- Serve as subject matter expert for Quality Assurance oversight of e-systems during regulatory inspections.
- Collaborate with corporate teams to ensure adherence to company policy and site SOP's.
Qualifications and Education Requirements
- BS or higher degree in an IT, engineering, scientific discipline or other related field.
- Fifteen (15) or more years of experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role with at least 3+ years in a leadership position.
- Expertise with 21 CFR Part 11 and GAMP standards for validation of automated systems is required.
- Experience with Quality Assurance oversight of e-systems for GMP operations is required.
- Demonstrated excellence in written and verbal communication.
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Demonstrated ability to work effectively with US FDA and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ISO and other applicable standards.
- Demonstrated record with driving continuous improvement and fostering a compliant operational excellence culture.
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a leader of team(s) to engage and influence team members in a matrixed environment.