Pharmaceutical company is looking for a senior manager, data integrity.
*** Must have 8+ years of pharma experience, with 3+ years in a leadership role
In this role, you will act as the site subject matter expert (SME) on data integrity, training and coaching staff on ALCOA+ principles and relevant worldwide regulations. You will develop and maintain integrated project plans to enhance our unique cell therapy supply chain's capabilities, efficiency, and performance. Collaborating with cross-functional teams, you will ensure that e-systems used in site operations comply with applicable regulatory requirements. Additionally, you will be responsible for regular reporting of data integrity metrics and partnering with the Global Data Integrity Center of Excellence to align with our global policies and strategies. Your leadership and ability to manage complex projects will be essential in fostering strong business relationships and ensuring successful project outcomes.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• 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 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 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 company Global Data Integrity Center of Excellence team to ensure adherence and alignment to Global DI policies and strategy as defined by the company Global DI program.
Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning.
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