Associate Director EU Batch Release

Associate Director EU Batch Release - QP and RP

Hybrid role: based in Copenhagen, Denmark (3 days office, 2 days home)

Salary: Competitive + Benefits + Bonus

If you are an agile, committed, and strategic quality professional, with experience of leading QA teams and eligibility as QP and RP, then we want to hear from you

Join us to help improve peoples' lives and make healthcare better for everyone

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future - in our products, our brands, and our people.
• We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, Spain, and South Korea.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

As Associate Director for EU Batch Release you will be responsible for the day-to-day management of the QA team in the Denmark office and for the activities relating to operational quality for EU supply of medicinal products.

You will take legal accountability for the legal and routine duties of the QP and RP roles, and therefore need to be eligible to be named as Qualified Person on the Atnahs Pharma Denmark ApS Manufacturing and Importation Authorisation (MIA) and as Responsible Person on the Atnahs Pharma Denmark ApS and Pharmanovia A/S Wholesale Distribution Authorisations (WDA)s.

As well as managing the Quality team in Denmark, you will form strong working relationships with the global QA team and other Pharmanovia affiliate QA teams.

Key skills are a strong working knowledge of EU GMP and GDP, strong leadership and management skills, the ability to communicate proactively, clearly and concisely both internally and externally.

The department has an ethos of continuous improvement. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

This role reports into the Director for Quality Operations.

Main responsibilities & duties:

Associate Director:

• Management of the QA team in Denmark
• Liaison with other QA sub-function leaders to ensure clear communication and oversight is in place where needed
• Strive for Quality Excellence and continuous improvement activities

Qualified Person:

• Accountable for execution of legal and responsibilities of a Qualified Person as per 2001/83/EC Article 51
• QP certification and release of imported medicinal products from 3rd country to Atnahs Pharma Denmark
• QP certification and release of EU manufactured products
• Oversight of the Pharmaceutical Quality System (both global and local) and records relating to activities in or on behalf of Atnahs Pharma Denmark ApS
• Ensure QA team in Denmark are trained and competent in the tasks they are responsible for
• Ensure that all Atnahs Pharma Denmark ApS activities are performed in accordance with EU GxP
• Maintenance of MIA and GMP certificate
• Maintenance of Narcotic substances licences

Responsible Person:

• Accountable for the execution of the duties of a Responsible Person as per 2013/C 343/01 for both Atnahs Pharma Denmark ApS and Pharmanovia A/S WDAs
• Ensure that a quality management system is implemented and maintained
• Ensure that initial and continuous training programmes are implemented and maintained
• Coordinate/support and promptly perform any recall operations for medicinal products related to Atnahs Pharma Denmark ApS or Pharmanovia A/S
• Ensure that relevant quality or distribution complaints are dealt with effectively
• Ensure that suppliers and customers are approved
• Approving any subcontracted activities which may impact on GDP
• Ensure regular monitoring of GDP suppliers
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
• Keep appropriate records of delegated duties
• Decide on the final disposition of returned, rejected, recalled or falsified products
• Approving any returns to saleable stock (where described by QTA)

About you:

Candidates with experience of working as a QP and RP within a pharmaceutical company/distribution environment should have the necessary skills and experience required for this role. We are also looking for:

• Bachelor's degree in chemistry, biology or pharmaceutical science
• Postgraduate degree in pharmaceutical studies or equivalent is desirable
• Eligible to be added as a QP to an MIA under the permanent provisions of Directive 2001/83/EC for Medicinal Products for Human Use
• Eligible to be named as RP on EU WDA as per 2013/C 343/01
• Proven experience of hosting and supporting Regulatory Inspections
• Excellent working knowledge and application of Current EU Guide to GMP and EU GDP
• Good working knowledge of Quality Risk Management
• Proven experience of supporting manufacture and packaging of solid dosage forms, liquids, creams and sterile products
• Proven experience of hosting and supporting Regulatory Inspections
• Significant previous experience within Quality Assurance, creating or reviewing policies and procedures, internal auditing, reviewing deviations, change control requests, CAPA etc.
• Experience and confidence in managing teams, understanding of difference between leadership and management
• Excellent communication skills both written and oral, and ability to forge good working relationships with internal and external customers
• Calm, systematic, logical thinker, with ability to focus on priorities whilst coordinating multiple issues
• Commitment to quality, patient safety and achieving the best outcome with a pragmatic and strategic approach
• Excellent time management skills
• Positive attitude and flexible approach to work
• Fluency in both Danish and English languages

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.