Position Summary The Manager QA (Sterile & Injectables) is responsible for strategic direction, oversight, and execution of all site Quality Operations. This role ensures the facility maintains strict compliance with current Good Manufacturing Practices (cGMP) and global regulatory expectations (such as USFDA). The incumbent governs aseptic controls, terminal sterilization, contamination prevention, cleanroom validation, batch certification, and drives a proactive culture of data integrity.

Key Responsibilities Aseptic Processing & Sterile Oversight:

Lead and enforce the site Contamination Control Strategy (CCS), environmental monitoring programs, and aseptic validation protocols.

Documentation Control :

Responsible for implementation of GDP and documentation control system at site including SOPs, Protocols and reports.

Qualification and Validation :

Directly and oversee the complete site qualification and validation activities Terminal sterilization &

Validation:

Direct and oversee cleanroom operations, terminal sterilization (terminal sterilization, autoclaves, dry heat) and visual inspection frameworks. Quality Management Systems (QMS): Own and continuous improve the site QMS framework covering deviations, Out-of-Specification (OOS) / Out-of-Trend (OOT) events, Change Controls, market complaints, Non-conformance, CAPAs, FAR, APQR etc

IPQA & Batch Release Execution:

Review and monitoring IPQA control. Act as the principal authority for review and approval of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and ultimate batch certification. Review of QC and microbiology analytical documentation.

Audit Readiness & Governance:

Lead the facility through global health authority inspections (USFDA); manage robust internal audit and comprehensive vendor qualification programs.

Data Integrity Standards:

Enforce unwavering compliance with ALCOA+ data integrity guidelines across all production lines and laboratory data execution.

Critical Engineering Utilities:

Provide quality engineering oversight for critical plant utilities including HVAC, Water-for-Injection (WFI), Pure Steam, and process automated equipment.

Talent Management & Training:

Structure ongoing site-wide technical training programs specifically focused on aseptic gowning, sterile behaviors, and root-cause analysis methodologies.

Core Technical Competencies Sterile Manufacturing Engineering:

In-depth knowledge of advanced aseptic processing, cleanroom classification standards (ISO / EU area classification), and sterilization science.

Global Regulatory Mandates:

Expertise in international cGMP mandates (FDA 21 CFR Parts 210/211, EU GMP Annex 1 guidelines, ICH guidelines). Root Cause Analysis (RCA): Experienced in tracking systematic quality failures using standard methodologies like Fishbone, 5 Whys, and FMEA risk maps.

Digital & CSV Compliance:

Mastery over computerized system validation (CSV) and automated control system oversight inside sterile units.

Qualifications & Requirements Education:

Master of Science in Pharmacy, Chemistry, Microbiology, or highly related Life Sciences.

Experience Profile:

12 to 20+ years of operational pharmaceutical QA experience, with a mandatory minimum of 5 to 7 years in a senior leadership role over an active sterile/injectable facility.

Audit Profile:

Documented success in spearheading and successfully defending a sterile manufacturing site during complex USFDA, EMA, or equivalent audits.

Benefits:

Dental insurance Health insurance Paid time off Vision insurance

Education:

Master's (Preferred)

Work Location:

In person