On-Board Administrative is hiring a Sr. Manager, Data Integrity

For immediate consideration please send your resume to
Subject Line: Position Title and State you areLocated
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Position Type: Contract
Job Location: Bothell, Wa
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation: $ 200-210/hour

Job Description: 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 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 Global Data Integrity Center of Excellence team to ensure adherence and alignment to Global DI policies and strategy as defined by the Client Global DI program.
Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning.
Additional Job Requirements:
None
Apply Today!

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board s Mission is to provide Flexible Service by applying the talents of our people, work processes and technology to meet our clients expectations in a Safe, Responsible and Dependable manner.

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.