Sr Manager Data Integrity - Bothell, WA

Sr Manager Data Integrity - Bothell, WA

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Position Summary : 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.

Duties / Responsibilities :

• 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.
• This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability process mapping, data backup / restore, electronic signature / electronic record linking and data audit trails.
• 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.

Reporting Relationship : This position reports into the Sr Director Quality Systems and Compliance.

Minimum Education Required : High School / GED

Job Category : Management

Additional Qualifications / Responsibilities : Qualifications Specific Knowledge, Skills, Abilities : 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. Education / Experience / Licenses / Certifications : BS or higher degree in an IT, engineering, scientific discipline or other related field or equivalent combination of experience and education.

Compensation Overview : Bothell - WA - US : $142,550 - $172,741 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

City : Bothell

State : Washington

Job Code : Pharmaceutical Pharmaceutical

Company : Bristol Myers Sqibb BMS

Salary Range : >

$100,000