STADA Pymepharco (Headquartered: Germany)

Position: Quality Assurance Head/QA Head | EU-GMP

Working location: Factories - Tuy Hòa City, Phú Yên (now Tuy Hoà Ward, Đăk Lăk)

Reporting line: Site Quality Head

Open both local & expatriates who have +5 years management roles in Pharma industry which EU-approved manufacturing or at MNC and open to relocate in Tuy Hoa with good command of English

Scope of work

QA Head plays an important role in 4 key parts: (1) Lead & manage QA organization +50 members (2) Oversee the Quality Assurance function in pharmaceutical manufacturing in compliance with regulatory standard (3) Involves active in STADA global quality audits and regulatory inspections for EU, DAV, and emerging markets (4) Lead internal/external audit/regulatory inspections:

• Lead the team responsible for Quality Operations, Quality Systems & Improvement, and Quality Compliance, ensuring effective QA oversight for the site, in alignment with regulatory requirements and STADA global quality policies.
• Develop, implement, and oversee Quality Assurance strategies to ensure compliance with GMP, GLP, and regulatory requirements (DAV/EU/WHO/ICH).
• Lead internal audits and prepare for external audits and regulatory inspections.
• Provide technical support for GMP and Quality activities in manufacturing.
• Review and approve key documents regarding cGMP standards such as batch records, validation protocols, and quality documentation.
• Investigate product quality issues and implement corrective and preventive actions (CAPA).
• Review and approve major deviations and non-conformance (NC) investigation reports.
• Manage & utilize digital QA systems like Electronic Quality Systems, Electronic documentation system, SAP/LIMS to optimize QA processes; including document control, deviation management, CAPA, change control, and risk management.
• Support the Site Quality Head during global audits and inspections for EU, DAV, and emerging markets.
• Collaborate with cross-functional teams to ensure compliance and smooth operations.
• Drive continuous improvement initiatives to enhance quality systems and processes.
• Responsible for compiling and reviewing QA data for Monthly MBR, QMBR presentations.
• Oversee personnel management, including training, coordination, and organizational deliverables, while fostering a culture of quality and excellence.
• Manage QA budgeting, resource planning, and improvement projects.

Key requirements

• 15+ years of experience in pharmaceutical QA/QC/CSV, including 5+ years in management roles within highly regulated environments
• Experience USFDA/EU-approved organizations OR from multinational companies, managing QA systems and teams.
• Deep knowledge of GMP, GLP, ICH guidelines, and regulatory requirements for pharmaceutical manufacturing and computer system validation requirements.
• Proven experience in handling audits and inspections by regulatory authorities such as USFDA, EU, and WHO.
• Strong leadership, problem-solving & decision-making ability
• Open-minded, collaborative & strong at communication
• Good command of English (verbal-verbal) | value if candidates can speak Vietnamese
• Hand-on experience in digital systems (Electronic Quality Management Systems, Electronic documentation system, SAP/LIMS/QC software)
• Experienced in solid oral dosage forms and sterile dosage forms is a plus point

Why join us?

• Global Standards: One of only three pharmaceutical companies in Vietnam holding EU-GMP certification for the EU market.
• Global Client Trust: Trusted by partners and customers across Vietnam and international markets (EU, SEA, and emerging markets).
• International Exposure: Opportunity to collaborate and work closely with global teams.
• Business Expansion: Strong growth focus on EU and emerging markets.
• Top-Tier Facilities: Two WHO-GMP and EU-GMP certified manufacturing sites in Tuy Hoa (formerly Phu Yen), equipped with state-of-the-art pharmaceutical technology.
• People-Centric Culture: Open, collaborative, and friendly working environment that values people and long-term development.

How to apply?

Apply directly to the job post or inbox me for any question come up.

Look forward to meeting you soon!

*Note: Only qualified candidates could be contacted (after Tet holiday)