Senior Manager

Key Responsibilities

Validation Governance & Strategy

• Develop, implement, and maintain a comprehensive Validation Master Plan (VMP) aligned with corporate quality systems and regulatory expectations.
• Ensure lifecycle approach to validation: User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Continued Process Verification (CPV).
• Establish validation policies, SOPs, and templates in line with PIC/S PE 009, WHO TRS Annexes, EMA Annex 15, and ISPE Baseline Guides.
• Lead risk-based validation programs using ICH Q8, Q9, Q10, Q12 principles.

Process & Cleaning Validation

• Lead planning and execution of process validation (PPQ) in accordance with EMA Annex 15 and FDA Stage 1–3 lifecycle guidance.
• Oversee cleaning validation strategies, including worst-case selection, MACO calculation (ISPE/ECA), and visual inspection standards.
• Ensure re-validation and periodic review in line with lifecycle management requirements.

Facility, Equipment & Utility Qualification

• Manage qualification of HVAC, WFI, compressed gases, cold rooms, isolators, RABS, and other critical systems.
• Oversee validation of aseptic areas as per WHO/PIC/S/Annex 1 contamination control strategy.
• Ensure alignment of qualification protocols with ISO 14644, EN 285, and ISO 8573 standards where applicable.

Computerized Systems Validation (CSV)

• Lead CSV and Data Integrity program in accordance with GAMP 5, PIC/S PI 011, and 21 CFR Part 11/Annex 11 requirements.
• Ensure risk-based validation, vendor audit management, and ongoing periodic reviews of critical systems (LIMS, SAP, MES, SCADA, etc.).

Analytical Method & Equipment Validation

• Ensure analytical method validation and verification as per ICH Q2(R2) and USP/EP requirements.
• Oversee qualification of laboratory instruments and computerized systems (e.g., HPLC, GC, UV, Empower).

Documentation & Compliance

• Review and approve validation protocols, reports, deviations, and change controls.
• Maintain validation traceability matrix ensuring compliance with ISO 9001:2015 and GMP data integrity principles (ALCOA+).
• Support internal and external audits (PIC/S, WHO, EMA, US FDA, ISO 13485 where applicable).

Leadership & Continuous Improvement

• Build and mentor a high-performing validation team with expertise across disciplines.
• Drive harmonization of validation approaches across sites/facilities.
• Benchmark validation programs with ISPE/ECA best practices and implement continuous improvement initiatives.

Required Experience, Knowledge & Skills

• Master's degree in Applied Chemistry, Chemistry, Pharm D, or a related scientific discipline from a recognized university or accredited institution.
• A minimum of 12 to 15 years of progressive, hands-on experience in validation and qualification activities within the pharmaceutical industry, with a solid track record of implementing and managing validation programs in compliance with regulatory expectations.
• At least 4 years of experience in a leadership, supervisory, or managerial capacity, overseeing multidisciplinary validation teams and coordinating cross-functional collaboration with departments.
• Strong expertise in equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, HVAC system validation, and computer system validation (CSV).
• Proficient in preparing and managing Validation Master Plans (VMPs), protocols, risk assessments, and deviation investigations, ensuring full compliance with cGMP and regulatory requirements.
• Experience in regulatory audit readiness, including WHO inspections, ISO audits, and audits by national regulatory authorities.
• Demonstrated ability to manage validation lifecycle documentation using electronic quality management systems (eQMS) and other compliant documentation tools.
• Strong leadership and interpersonal skills, with a proven track record of managing cross-functional teams and mentoring junior professionals in validation disciplines.
• Effective project management and time management skills, with the ability to prioritize and execute multiple complex projects under strict regulatory timelines.
• Clear and professional communication skills for cross-functional collaboration, technical report writing, and audit representation.