Quality Manager, Data Integrity

Location

Newark, DE | United States

Job description

Job Description

This position has a global responsibility for the programmatic oversight and execution of the Data Integrity strategy for the Pharma Solution’s (PhS) manufacturing sites.

Responsibilities:

Data Integrity Strategy

• Lead the Governance Committee for Data Integrity for Pharma business unit and manage its structure, membership, responsibilities, and activities to support site implementation and global initiatives.
• Lead gap assessment efforts for new and existing regulations and guidance, identify gaps requiring remediation, and propose plan(s) for approval and execution.
• Identify and maintain inventory of all policies and procedures that include data integrity relevant requirements.
• Identify and maintain collection of appropriate resource materials for all functional areas including laws, regulations, guidance, guidelines, and directives.
• Ensure incorporation of new regulatory requirement(s) into the Quality System.
• Ensure that effective policies, procedures, and practices are in place to support data integrity

Data Integrity Plan

• Work with the ten (10) Pharma Solutions Site Heads/Site Quality Managers in a matrix environment to implement the plan, establish timelines, identify CAPAs, and track progress. 
• Lead or participate in the DI assessments of computerized systems for each of the ten (10) Pharma Solutions sites.
• Develop and track KPIs for progress against the Data Integrity Strategy and Plan.
  

Data Integrity Subject Matter Expert

• Ensure a process is developed and utilized to identify, escalate, and resolve suspected data integrity issues within the structure of the QMS. Participate in the process and ensure activities are documented within the QMS.
• Responsible for developing strategic and collaborative partnerships with the enterprise validation team and IT leadership. Act as the trusted partner and advisor to all stakeholders.
• Serve as content SME for the development of education/training.
• Ensure that adequate education and training are provided and provide training to staff based on their functional responsibilities.
• Seek out and recommend to management opportunities for increased data integrity program efficiencies and operational improvement.
• Support sites in responding to DI audit findings and identify appropriate CAPAs.
• Assist in establishing budgets for data integrity initiatives

Qualifications :

• BS Degree in Microbiology, Chemistry, Biological Sciences, Food Technology, or related Science field.
• Demonstrated understanding of data integrity and regulatory requirements for food, excipients, cosmetics, and/or API.
• Experience working in a Good Manufacturing practice environment
• Ability to work independently to manage work progression and time.
• Shows initiative beyond the scope of a project/task.
• Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure
  

Job tags

Salary