This position is the lead responsible for the implementation and management of Bristol Myers Squibb's GMP Data Governance and Data Integrity programs at the Bothell, WA manufacturing facility.
Serve as the site DI subject matter expert (SME) and promote/train/coach site staff on ALCOA+ principles and associated worldwide regulations.
Ensure site meets the expectations of the Global BMS Data Integrity program, including but not limited to the annual DI Master Plan, DI training curriculum ownership, and launching DI related initiatives to promote the DI culture within the organization.
Ensure the validation, implementation and change management of e-systems used across the site operations are conducted in compliance with applicable Data Integrity related regulatory requirements (FDA, EMA, etc).
Responsible for ensuring systems at the Bothell site comply with data life cycle requirements from initial data creation/recording to archival and decommissioning.
Responsible for leading, reviewing, and approving data integrity assessments for GxP systems and processes including, but not limited to, manufacturing and laboratory systems/processes to ensure compliance with regulatory requirements and company established requirements for data integrity.
Effectively partner with cross-functional stakeholders to ensure both systems and processes are DI compliant through governance and risk control, and drive mitigation/remediation actions when DI gaps are identified.
Periodically report the Data Integrity metrics of the site through the Site Quality Management Review and to the Global DI COE.
Collaborate with BMS Global Data Integrity Center of Excellence team to ensure adherence and alignment to Global DI policies and strategy as defined by the BMS Global DI program.
Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning.
Eight (8) or more years of relevant work experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance role.
Expertise with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems is preferred.
Experience with QA oversight of e-systems for GMP operations is preferred.
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, EU and other regulatory agencies.
Substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and other applicable standards.
Demonstrated expertise in Data Integrity principles and GxP knowledge with ability to recognize Data Integrity risks and develop mitigation plans.
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.
Demonstrated experience utilizing Risk Management tools (e.g. FMEA, FTA tools) to understand and reduce overall risks through effective CAPA planning and implementation.
Experience performing site and functional audits and walk-throughs.
Experience with QA oversight of e-systems for GMP operations is preferred.
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.