Site Data Integrity & Governance Lead (Pharma)

Berkshire Sterile Manufacturing Llc; Lee (MA); On-site; USD 100,000 - 120,000; Full time

Job summary

Berkshire Sterile Manufacturing Llc is seeking a Senior Manager, Data Integrity & Governance to lead site data integrity initiatives and ensure ALCOA+ compliance across computerized and paper systems.

The role partners with IT, Manufacturing, Quality, and Engineering to implement risk-based data governance, support regulatory inspections, and drive continuous improvement in data integrity programs. Strong leadership and communication are essential.

Qualifications

• Minimum 5 years in data management and governance with ALCOA+ focus.
• Leadership experience in pharmaceutical data integrity initiatives.
• Expertise with 21 CFR Part 11, EudraLex Annex 11, and GAMP standards.
• Experience coordinating cross-functional investigations, CAPAs, risk assessments, and remediations.
• Excellent written and verbal communication with ability to influence stakeholders.

Responsibilities

• Define and manage the Site Data Integrity Management Program, including objectives and scope.
• Serve as SME during regulatory inspections and audits; train personnel on ALCOA+ and related guidance.
• Report to the Site Quality Head and participate in Quality Leadership governance.
• Provide leadership to Data Integrity representatives across site units.
• Ensure risk-based methodologies are understood and applied for legacy and new computerized systems.
• Collaborate with corporate Data Governance, Quality, and IT to integrate data integrity into governance framework.
• Oversee cross-site alignment of roles and responsibilities for data management and stewardship.
• Lead or support risk assessments, investigations, CAPAs, and remediation plans.
• Ensure data integrity considerations are included in system validation, change control, and incident management.
• Review and trend metrics; communicate status and risks to site leadership; drive improvements and inspection readiness.

Skills

Data integrity

Governance

ALCOA+

Leadership

Quality systems

Regulatory compliance

Risk assessment

Cross-functional collaboration

Project management

Communication skills

Education

BS or higher in IT/engineering/science

Tools

GAMP5

21 CFR Part 11

EudraLex Annex 11

Job description

Berkshire Sterile Manufacturing Llc is seeking a Senior Manager, Data Integrity & Governance to lead site data integrity initiatives and ensure ALCOA+ compliance across computerized and paper systems.

The role partners with IT, Manufacturing, Quality, and Engineering to implement risk-based data governance, support regulatory inspections, and drive continuous improvement in data integrity programs. Strong leadership and communication are essential.