Site QA Head

Oncology OSD Manufacturing Plant

Position Details

- Position: Site QA Head
- Function: Quality Assurance
- Plant: Oncology Oral Solid Dosage (OSD) Manufacturing Facility
- Experience: Minimum 15 years
- Reporting To: Director – Technical Operations
- Team Responsibility: Complete Site Quality Assurance and Compliance Team

Role Objective The Site QA Head will be responsible for leading the complete Quality Assurance and regulatory compliance function of the Oncology OSD manufacturing facility. The incumbent will ensure that all manufacturing, testing, packaging, validation and support activities are performed in accordance with cGMP requirements, approved quality systems and applicable regulatory standards. The role requires strong experience in handling USFDA-regulated facilities and prior exposure to Oncology/Cytotoxic OSD manufacturing operations.

Key Responsibilities

1. Site Quality Leadership

- Lead the complete Quality Assurance function covering manufacturing, packaging, warehouse, QC, engineering, utilities and other support functions.
- Establish and maintain a strong quality and compliance culture across the site.
- Ensure consistent adherence to cGMP, data integrity, contamination-control and regulatory requirements.
- Act as the principal Quality representative for all site-level operational and compliance matters.
- Provide timely quality-related inputs for production planning, product release and business decisions.

1. Regulatory Compliance and Inspections

- Lead the preparation, coordination and successful handling of USFDA inspections and other regulatory audits.
- Handle regulatory agencies and customer audits, including inspection planning, facility walkthroughs, document-room management and response coordination.
- Review and ensure timely closure of regulatory observations, Form 483 observations, warning-letter concerns, audit findings and commitments, wherever applicable.
- Conduct periodic gap assessments against current USFDA and international regulatory expectations.
- Ensure that the site remains in a state of continuous inspection readiness.

1. Oncology and Cytotoxic Manufacturing Compliance

- Ensure implementation of appropriate containment, segregation and contamination-control systems for Oncology and Cytotoxic products.
- Review and monitor procedures relating to personnel movement, material movement, pressure differentials, air-handling systems, cleaning and decontamination.
- Ensure effective prevention of cross-contamination and occupational exposure.
- Verify compliance of facility design, equipment,



utilities and operational practices with Oncology/Cytotoxic manufacturing requirements.
- Ensure appropriate handling of potent compounds, waste disposal and product-changeover activities.

1. Pharmaceutical Quality Systems

Lead and monitor the effective implementation of:
- Deviations and incident investigations
- Corrective and Preventive Actions (CAPA)
- Change controls
- Out-of-Specification and Out-of-Trend investigations
- Market complaints and product-quality complaints
- Product recalls and mock recalls
- Annual Product Quality Reviews
- Quality Risk Management
- Document control and archival
- Training and qualification systems
- Vendor qualification and supplier quality management
- Self-inspection and internal audit programmes
- Management review and quality metrics

1. Batch Review and Product Release

- Ensure timely review of batch manufacturing, packaging and analytical records.
- Ensure that products are manufactured, tested and released in compliance with approved procedures, specifications and regulatory filings.
- Review critical deviations, investigation reports, analytical failures and quality-risk assessments before batch disposition.
- Ensure proper management of rejected, returned, reprocessed and reworked materials or products.

1. Validation and Qualification

- Provide Quality oversight for qualification and validation activities, including:

- Facility and equipment qualification

- HVAC and utility qualification

- Process validation

- Cleaning validation
- Analytical method validation and transfer
- Hold-time studies

- Computerised system validation

- Transport validation

- Continued process verification
- Ensure validation programmes adequately address the specific risks associated with Oncology and Cytotoxic manufacturing.

1. Data Integrity and Quality Governance

- Ensure compliance with ALCOA+ principles across manufacturing, laboratory and computerised systems.
- Strengthen systems for audit trails, electronic records, access controls and review of critical data.
- Identify potential data-integrity risks and ensure appropriate remediation and monitoring.
- Review site quality metrics and present quality performance to senior management.




- Escalate significant compliance or product-quality risks to the management promptly.

1. Investigation and CAPA Effectiveness

- Ensure investigations are scientifically sound, evidence-based and completed within defined timelines.
- Guide cross-functional teams in root-cause analysis using appropriate investigation tools.
- Ensure CAPAs address the actual root cause and are monitored for effectiveness.
- Identify recurring compliance issues and initiate systemic improvements.

1. Team Leadership and Development

- Lead, coach and develop the Site QA team across all QA sub-functions.
- Define clear roles, responsibilities, KRAs and performance standards for team members.
- Develop succession plans and build technical and regulatory capabilities within the Quality team.
- Ensure that employees and contractual personnel receive appropriate cGMP, data-integrity and Oncology-safety training.
- Promote accountability, quality ownership and proactive risk identification across departments.

Required Qualification
- M.Pharm, B.Pharm, M.Sc. or an equivalent qualification in Pharmaceutical Sciences, Chemistry or a related discipline.
- Additional qualifications or certifications in Quality Management, Regulatory Compliance, Auditing or Lean/Six Sigma would be preferred.

Experience Requirements
- Minimum 15 years of experience in Pharmaceutical Quality Assurance and Compliance.
- Significant experience in a leadership role within an Oral Solid Dosage manufacturing facility.
- Mandatory experience of working in an Oncology/Cytotoxic manufacturing plant.
- Proven experience in handling USFDA inspections and maintaining compliance at a USFDA-regulated facility.
- Hands-on experience in managing complete site-level pharmaceutical quality systems.
- Experience in regulated markets such as the US, EU, UK, Canada, Australia or other major international markets would be preferred.
- Exposure to remediation projects, warning-letter responses, consent-decree environments or major compliance transformation projects would be an advantage.

Candidates must have:
1. Minimum 15 years of pharmaceutical QA experience.
2. Current or recent responsibility for a complete Site QA function.
3. Direct experience in an Oncology/Cytotoxic OSD manufacturing facility.
4. Hands-on experience in facing or leading USFDA inspections.
5. Strong exposure to investigations, CAPA, change control, validation, batch release, data integrity and regulatory compliance.
6. Willingness to operate from the plant location on a full time basis.

📌 Site Quality Lead (Vadodara)
🏢 BDR Pharmaceuticals
📍 Vadodara