Quality Affairs Project Manager CZ/SK/HU
- Contract Type
Position: Quality Affairs Project Manager CZ/SK/HU
Location: Czech Republic
Salary: Competitive + benefits
An exciting opportunity to join a dynamic, game-changing team within a multinational healthcare company with a diverse portfolio. The role as been created to perform and support quality operations and ensure full compliance with quality requirements in the relevant countries. The role has cross country responsibilities with main focus on quality operations in Czech and Slovak Republic and oversee and support quality operations in Hungary. The role will attract a higher level of autonomy and responsibility for management of workload and priorities. This person will lead the quality operations and will be the QP (responsible person) in CZ and SK and will also work with and supervise the local quality responsible person in Hungary to ensure full quality compliance. This person will be an integral part of the Regulatory, Quality, Safety team in CZ/SK, aiming to be best in class in the industry, and will be visible to senior levels of the business.
- Ensuring compliance with all legal obligations and quality requirements for the company product portfolio in CZ/SK and HU in the area of drugs, medical devices, food supplements, cosmetics and biocides. Including establishing, oversight, identification, training and monitoring of process improvements and ongoing-compliance.
- Establishment and maintenance of quality :
- CZ/SK: CE certification, ISO 9001, ISO 13485 maintenance in CZ/SK. Ensuring compliance with GDP and responsible for all relevant local quality operations and systems including local batch release and audits etc. Supervise the quality of contract manufacturing.
- HU: Supervise and support the local QP/responsible person in Hungary to ensure compliance with GDP and quality requirements.
- Qualified Person/Responsible person in CZ and SK. Responsible for all local QP activities for medicines including batch release, warehouse, supplier and self-audits and trainings. Ensure full quality compliance and batch release according to ISO and other relevant requirements for all product types in the portfolio of the company (medicines , medical devices, cosmetics, food supplements and biocides)
- Ensure that suitable Quality systems are in place: Prepare, review, update and train out SOPs and processes for quality systems and operations in CZ/SK. Supervise and support the local quality responsible person in HU to ensure that suitable quality system is in place.
- Responsible for complaint management process and complaints assessment for all types of products in the company portfolio in CZ/SK/HU
- Internal Stakeholder Management: Effectively manage expectations across a broad range of business stakeholders, employing high quality communications in all interactions.
- External Relations: Continue to build strong relationships with relevant authorities, notified bodies and trade associations to ensure smooth and effective quality operations and form a go-to network for strategy development and problem solving. Responsible for communications with state health authorities and notified bodies regarding quality operations in the area of all product types in the local portfolio
- The role reports to the Head of Regulatory Affairs & Quality & Safety services in CZ and SK
Education & experience required:
- Pharmacist degree is required
- Substantial experience (3+ years) working within quality affairs for medicines and non-medicines
- Experience includes Medicines and Medical devices and Cosmetics
- Experience with Biocides, Food Supplements would also be beneficial.
- Substantial experience with GMP & GDP and ISO requirements and audits
- Local QP/responsible person experience in CZ and /or SK (2+ years), experience within batch release, recalls, audits and other relevant quality operations
- Experience with complaint management
- Experience with building and maintaining quality management systems
- Active English
Values & Competencies sought:
Show Passion and Energy
- Able to work independently and self-start to define a path and gather knowledge
- ‘Can do’ mentality, diving in from day 1 to get the job done
- Ability to prioritise in line with business needs, managing stakeholders & expectations.
Go The Extra Mile
- Always looks for opportunities to do more
- Takes initiative and takes risk when justified
- Displays thoroughness in analysis and follow-up.
Change the Game
- Generates creative solutions to problems faced
- Able to make decisions in ambiguous situations
- A ‘sales enabling’ regulatory mindset.
Be Curious and Savvy
- Curious about the OTC and non-medicine healthcare landscape and potential opportunities for Omega
- Savvy enough to understand the commercial priorities and identify opportunities that complement, building regulatory strategy which aligns to business need
- Ability to critique data, assess probability of success and adapt based on strength of position
- Impactful negotiator, able to adapt style to audience (Health Authorities, notified bodies etc).
Be Open and Gracious
- Demonstrates empathy & respect for people
- Fosters collaboration with other functions & departments, at all levels, and acts as an equal partner and valued voice in all interactions
- Communicates with confidence and tact
- Holds themselves and others accountable by confronting issues appropriately.
For more information, please reach out to me directly!
+44 1293 77 66 44
Barrington James is a uniquely successful specialist life science recruitment company and has recently been recognised as a BEST COMPANY To Work For by the Sunday Times. It has enjoyed an exceptional growth trajectory since its launch in 2002, and is now established in the heartlands of the international pharma, medical devices and healthcare industry with consultant staff already approaching 140, and planned to be 180 by the end of 2017.
Recruitment companies succeed by matching the specific needs of clients with the true capabilities of candidates. We believe there are 2 reasons for our outstanding performance over the past decade, which benefit our clients and our candidates equally; People & Knowledge Barrington James’ exceptional people and their depth of experience are ready to work for you, now.