Sr Manager Data Integrity Bothell, WA
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Job Location:
Bothell, WA - USA
Monthly Salary:
$ 142550 - 172741
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 Squibbs GMP Data Governance and Data Integrity programs at the Bothell WA manufacturing facility.
Duties/Responsibilities
Key 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.
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.
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Bothell - WA - US: $142550 - $172741
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 employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.
Required Experience:
Manager
Key Skills
- IDS
- System Design
- Haskell
- PCB
- Root cause Analysis
- Technical Writing
- System Security
- Federal Aviation Regulations
- Warehouse Distribution Experience
- Encryption
- Product Development
- Contracts
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
