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Open nowFirst seen 4 days ago

Site Quality Head (Pharma | Life Sciences)

HRTX1,628 open roles

Where
Calamba, Laguna, Philippines
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Your applicationOpen nowSite Quality Head (Pharma | Life Sciences)HRTX · Calamba, Laguna, Philippines

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: first seen 4 days ago

The posting

The Site Quality Head provides strategic and operational leadership across Quality Assurance, Quality Control, and Quality Systems within a regulated manufacturing environment. This role is accountable for ensuring full compliance with current Good Manufacturing Practices (cGMP), regulatory standards, and client requirements, while driving a culture of quality, continuous improvement, and inspection readiness.

The position serves as the key authority on all quality-related matters, including batch disposition, regulatory inspections, and quality systems governance, and acts as the primary liaison with regulatory bodies.

Key Responsibilities:

Quality Leadership & Governance

  • Lead and oversee end-to-end QA and QC operations, including raw materials, in-process controls, finished product release, microbiological testing, and stability programs.
  • Serve as the final authority for batch disposition, including approval or rejection of raw materials, packaging materials, and finished products.
  • Establish and maintain a robust Pharmaceutical Quality System (PQS) aligned with global regulatory expectations.

Regulatory Compliance & Inspection Readiness

  • Ensure compliance with cGMP, PIC/S, FDA, and other applicable regulatory standards.
  • Lead regulatory inspections, client audits, and internal audits; ensure timely closure of audit observations.
  • Act as the primary point of contact for regulatory authorities and external auditors.

Quality Systems Management

  • Oversee core quality systems including deviations, CAPA, change control, complaints, risk management, and validation.
  • Review and approve critical GMP documentation such as validation protocols/reports, SOPs, risk assessments, and investigation reports.
  • Ensure effective implementation of data integrity and documentation practices across all quality systems.

Operational Excellence & Continuous Improvement

  • Drive continuous improvement initiatives across manufacturing and quality processes to enhance compliance, efficiency, and product quality.
  • Provide strategic direction on validation, qualification, and process improvements.
  • Ensure effective product lifecycle management including stability and ongoing process verification.

Stakeholder Management

  • Collaborate cross-functionally with Production, Engineering, Supply Chain, and Technical Services to ensure alignment on quality standards.
  • Manage client communications related to quality concerns, product complaints, and recalls, ensuring timely and compliant resolution.

People Leadership

  • Lead, develop, and mentor QA/QC leaders and teams, including Quality Systems, Validation, and Compliance functions.
  • Establish training frameworks to ensure organization-wide adherence to cGMP and quality standards.
  • Build a high-performance culture focused on accountability, compliance, and continuous learning.

Scope of Responsibility

  • Direct oversight of QA, QC, Validation, Quality Systems, and Compliance Heads
  • Indirect oversight of laboratory analysts, specialists, and technical personnel

Qualifications:

Education

  • Bachelor's Degree in Pharmacy, Chemistry, Chemical Engineering, or related field
  • Licensed Pharmacist or Chemist preferred

Experience

  • Minimum 10+ years of progressive experience in Quality within pharmaceutical, biotech, or regulated manufacturing
  • At least 5 years in a senior leadership or site quality role
  • Strong exposure to regulatory inspections (e.g., FDA, PIC/S, EU GMP)

Technical Expertise

  • Deep knowledge of cGMP, Pharmaceutical Quality Systems (PQS), and regulatory frameworks
  • Strong experience in:
  • Batch release and disposition
  • Validation and qualification (process, cleaning, equipment)
  • Deviation investigation, CAPA, and change control
  • Product complaints and recall management
  • Supplier qualification and audits
  • Data integrity and risk management

Leadership & Competencies

  • Strong leadership presence with proven ability to manage cross-functional teams
  • High level of accountability and decision-making authority in regulated environments
  • Excellent stakeholder management and regulatory communication skills
  • Strategic mindset with strong execution capability
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