Title: Sr. Manager, Data Integrity Duration: 06 Months Location: West (Seattle/Bothell, WA)
PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the implementation and management of client's GMP Data Governance and Data Integrity program at the Bothell, WA manufacturing facility.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education: • BS or higher degree in an IT, engineering, scientific discipline, or other related field. Experience: • Eight (8) or more years of relevant work 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, EU Annex 11 and GAMP standards for DI and validation of automated systems is required. • Experience with QA oversight of e-systems for GMP operations is required.
Key Knowledge, Skills, and Abilities • 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.
DUTIES AND 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 client's 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 client's Global Data Integrity Center of Excellence team to ensure adherence and alignment to Global DI policies and strategy as defined by the client's Global DI program. • Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $180.00/hr.
