QA Manager

QA Manager

Syntese A/S

Become part of the quality leadership team and run a competent Quality Release Team, supporting the manufacturing of an Active Pharmaceutical Ingredient essential in the treatment of Inflammatory Bowel Diseases.

Syntese is looking for a driven and empowering QA Manager to take on the leadership of their Quality Release Team situated at the manufacturing site in Hvidovre. This is a unique chance to join an ambitious company at a time of change where you will be a valuable key figure on various projects, including compliance upgrades and alignment of quality systems and processes. Syntese truly encourages its employees to utilize their experience and competences to influence and make a difference.

Team leadership and involvement in exciting projects

As QA Manager, you will join Syntese’s Quality Organisation and be part of the Quality leadership team together with the Quality Head and QC Manager. You will be responsible for the Quality Release Team consisting of five QA Specialists, one QA Project Manager and two Student Workers. The team ensures release of materials and raw materials, API intermediates, and final API by making sure that batch documentation is reviewed and approved according to quality standards. Moreover, you will ensure a professional QA assessment of deviations, CAPA’s, changes, SOP’s etc. In addition, your team will provide QA support on Syntese’s largest and highest prioritised project as the manufacturing site in Hvidovre is undergoing a huge capacity expansion which will increase Syntese’s manufacturing capacity significantly.

As Syntese is moving towards being a fully integrated manufacturing company within Ferring Pharmaceuticals Group, the company has begun the process of aligning quality systems and processes. Therefore, you will monitor the quality systems together with the Quality Head, implement new quality activities and oversee projects within Compliance. Furthermore, you will participate as host or co-host during Authority inspections, global Ferring or partner inspections.

Your tasks will include, but not be limited to:

  • Lead the QA release team, including managing team performance and motivating employees to ensure effective and timely handling of daily tasks
  • Assure project management of various QA projects, including associated budgets
  • Ensure review, approval and of batch documentation, raw materials, process solutions, API intermediates and final API
  • Implement Quality activities and compliance upgrade in the QA Release team
  • Ensure professional QA assessment of deviations, CAPAs, changes, SOPs etc.
  • Ensure continuous trending of CQAs and CPPs and preparation of PQRs

Competent leader with GMP experience and a strong quality-mindset

You hold an academic degree in Pharmacy, Science or equivalent. You have several years of management experience as well as natural leadership skills characterised by empowerment and positivism. You have profound GMP experience from a pharmaceutical manufacturing company either in roles within QA, Compliance, QC and/or manufacturing. Preferably, you have +3 years of QA experience or at least a track record of close collaboration with Quality during your career.

You have good coaching skills and are able to set direction for employees in your area. With your great collaboration skills, you develop and encourage employees with ease and take a structured and transparent approach. You are outgoing and have a distinctly can-do attitude as well as a strong quality-mindset with ability to build a quality culture. Due to your strong stakeholder management skills, you manoeuvre effortlessly at all organisational levels. Besides, you are fluent in English in addition to being clear and respectful in your communication

Syntese offers

At Syntese, you will experience great space for action and the possibility to work independently in addition to having a high impact in the organisation due to Syntese’s empowering culture and very short decision paths. Working at Syntese, you will join Ferring Pharmaceuticals Group which is committed to supporting all employees in their career development and to ensuring all their team members receive the right level of support and progression. Ferring employs over 6,000 people across 56 countries and the diversity of their team brings exciting ideas and innovation. By working together, they can apply new science to unmet needs to help people live better lives.

Contact

The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Consultant, Emilie Tondering or Research Manager, Pernille Hemmingsen at +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

About Syntese

Syntese A/S is part of Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Syntese was founded in the early 1980s when a Ferring Group team in the Synthesis department invented the 5-ASA purification process that was to become the cornerstone of their business. Today, Syntese manufactures Mesalazine, an Active Pharmaceutical Ingredient (API) used in treating Inflammatory Bowel Diseases. Syntese is renowned worldwide for stable Mesalazine of exceptional quality. The company has been growing steadily during its lifespan and is now among the world’s biggest manufacturers of Mesalazine – and still the only company that is dedicated only to Mesalazine and nothing but. Syntese’s Mesalazine is registered in more than 90 countries, including the EU, the US, Canada, Japan, Australia, and Russia.

Deadline forapplication:As soon as possible
Workplace: Hvidovre, Greater Copenhagen
Reference: 2205344
Company:Syntese A/S