Senior Quality Assurance GDP Specialist

This is what you will do

We are seeking an experienced and highly motivated Senior GDP QA Specialist to support and strengthen our Good Distribution Practice (GDP) Quality Management System within a dynamic pharmaceutical environment.

Reporting to the GDP QA Manager, the successful candidate will operate with a high degree of autonomy, taking ownership of key GDP Quality Assurance activities and making sound, risk-based decisions to ensure regulatory compliance and business continuity.

This role is responsible for independently managing core quality processes, including deviations, change control, complaints, temperature excursion assessments.

The successful candidate will be expected to proactively identify quality and compliance risks, drive continuous improvement initiatives, and exercise independent judgment in resolving complex quality issues while ensuring alignment with GDP requirements and internal stakeholders requests.

This is an excellent opportunity for a quality professional with strong GDP expertise, excellent analytical and problem-solving skills, and a proven ability to work independently, prioritize competing demands, and make timely, risk-based decisions while maintaining the highest standards of product quality, regulatory compliance, and patient safety.

You will be responsible for

• Supporting the definition, implementation, and continuous improvement of Quality Systems aligned with GDP requirements and industry best practices.
• Managing, executing and/or supporting the following processes:
  • Deviations
  • CAPA
  • Change Control
  • Audits (internal, supplier, and customer)
  • Distribution Complaints
  • Supplier Qualification
  • Customer/Wholesaler Bona Fide
  • Quality and Technical Agreements with Customers/Suppliers
  • Shipping and transportation validation activities
• Ensuring proper record retention in accordance with GDP and internal standards.
• Participating in investigations and support the implementation and effectiveness check of Corrective Action Preventative Action.
• Ensuring quality risk management documentation is complete and up to date.
• Managing or support recall operations promptly
• Supporting the evaluation and management of returned, rejected, recalled, or falsified products.
• Reviewing temperature excursions and support the suitability assessment for product release or rejection.
• Ensuring customer complaints are handled efficiently and documented appropriately.
• Overviewing subcontracted GDP‑impacting activities when delegated.
• Supporting regulatory inspections and 3PL, customer audits.
• Partecipating in the definition of Quality metrics (deviations, CAPA, Change Control, KPIs and others)
• Representing the Quality GDP department during internal and external meetings when delegated.
• Performing Responsible Person responsibilities when required.
• Deputizing for the GDP QA Manager as needed to ensure continuity of operations and compliance.

You will need to have

• Qualification in a scientific or technical discipline and /or more than 8 years relevant industry experience
• Knowledge of Quality standards and Regulatory guidelines and requirements relating to pharmaceutical and/or biotech products
• Demonstrated skills and experience in the conduct of Quality activities as described above
• Experience in project management, analytical, problem-solving
• Good prioritization capability and comfortable adapting to meet changing priorities
• Ability to manage urgent situations effectively and rapidly switch focus between multiple topics and priorities as business needs evolve
• Demonstrated ability to work autonomously, exercise sound judgment, and make timely, risk-based decisions
• Excellent interpersonal skills and collaboration skills to optimise relationships with internal and external partners

We would prefer for you to have

• Comfortable working in an environment where the QMS will expand and grow in support of company growth
• Strong time management skills
• Willingness to learn and continuously improve skills
• Experience working with pharmaceutical products for rare diseases (orphan drugs) is considered a strong advantage

Location

The primary work location is Parma (Italy). The role offers flexibility, allowing candidates to be based across Europe, with regular travel to Parma required.

Compensation Range