STADA Pymepharco (Headquartered: Germany)

Position: Quality Control Head (QA Head) | EU-GMP

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

Reporting line: Functionally to Global QC Director and administratively to Site Quality head

Open both local & expatriates who have +15 years' experience in QA/QC, included +5 years management roles in Pharma industry which EU-approved manufacturing organization or at MNC and open to relocate in Tuy Hoa with good command of English

Scope of work

QC Head play an important role in Supply chain flow which focuses on (1) Oversee the Quality Control function in pharmaceutical manufacturing, ensuring analytical correctness, regulatory compliance, method transfers, and the timely release of raw materials, intermediate bulk, and finished products (2) Manage QC laboratories, including physio-chemical and microbiology units, while developing QC strategies and (3) Serving as the lead during global quality audits and regulatory inspections for EU, DAV, and emerging markets:

• Lead and manage the QC department including physio-chemical analysts and microbiologists.
• Oversee all analytical testing for incoming materials, in-process samples, intermediate bulk, finished products, technology transfer validation batch samples and stability samples.
• Review and approve the COAs, release decisions for incoming materials and batches in accordance with specifications and SOPs.
• Coordinate with Technology transfer teams for analytical method transfers between Stada global AST, QC labs for transfer products.
• Develop and implement QC SOPs, analytical procedures and method validation programs in accordance with national and international GMP regulations and pharmacopeias.
• Maintain strict compliance with Stada SOPs, cGMP, EU guidelines and local DAV regulations.
• Ensure the laboratory instruments, equipment and computerized systems are calibrated and validated in compliance with cGMP expectations and Stada global policies.
• Implement lean practices in laboratories and ensure integrity, accuracy in testing and documentation.
• Manage laboratory Quality systems, deviations, OOX investigations, change control, CAPA and documentation.
• Responsible for demonstrating the lab operations and systems for regulatory inspections
• Train and mentor QC staff, build technical competency and promote Quality culture.
• Actively participate in MRP2, CRP and supply review meetings.
• Responsible for performance management for QC labs with defined KPIs and report the metrics to global QC head, monthly MBR, QMBR meetings.
• Manage and control QC budgeting, resource planning, negotiating testing contracts for QC laboratories include calibration, instrument validations, annual maintenance, consumables management including OpEX, Capex and improvement projects.
• Support the compliance, regulatory activities as required, and any other responsibilities as assigned by site quality head.

Key requirements

• 15+ years of experience in pharmaceutical manufacturing QC/QA, including 5+ years in management roles within highly regulated environments
• Experience USFDA/EU-approved organizations OR from multinational companies, managing large QC teams, and conducting testing on pharmaceutical raw materials and dosage forms, including solids and small volume injectables.
• In-depth understanding of GMP/GLP, Stability Testing (ICH/WHO/EU), analytical techniques such as HPLC, GC, UV, LCMS/ICPMS, and microbial testing, including sterility.
• Familiarity with digital application systems such as LIMS, SAP, and Electronic Quality Systems.
• 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

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)