Senior QA GMP Manager

<p><span>Currently, we are looking for a Senior QA GMP Manager with compliance insight to support and oversee our GMP activities at Zealand, with report to our Senior Director and Head of GMP QA. You will be a part of a GMP QA team that covers all aspects of QA from product and device development to commercial medicinal and combination products. </span></p><p></p><p><span>You will be welcomed as a part of our ambitious and passionate Zealand family working seamlessly and effectively in a fast-paced environment providing life changing medicines.<span>  </span></span></p><p></p><p><b>Job Profile</b></p><p>The successful candidate will be responsible for all QA aspects in commercial drug substance, drug product, and combination product production, testing and distribution and launch activities with partners and CMOs. The right candidate will apply a compliant quality mindset and be a team player, grounded in QA knowledge with a proven track record in managing late-stage and commercial products.<br/> </p><p>Since our products are drug-device combination products, knowledge of quality assurance for device development is an advantage, but not a prerequisite. The ability to maintain strong relationships and oversight of internal stakeholders, suppliers and partners in our outsourced business model is key to our success.</p><p></p><p>The role includes tasks such as:</p><ul><li>Responsible for selected commercial products, providing timely quality advice and product approvals.</li><li>Lead QA aspects of commercial product launch activities, including setup of manufacturing, packaging, labeling, serialization and logistics.</li><li>Daily collaboration with the internal stakeholders such CMC and Device development and manufacturing, logistics, Regulatory, Commercial teams, as well as external CMOs and partners to maintain oversight and ensure compliance.</li><li>Participate in CMC project teams and/or commercial launch teams, providing both strategic and operational QA input.</li><li>Act as QP delegate and perform batch certification.</li><li>Lead or participate in internal and external audits within GMP and GDP.</li><li>Support preparation activities for Health Authority inspections and partner audits.</li><li>Contribute to the maintenance and development of the Quality System within the GMP area to support compliant and efficient operations.</li></ul><p></p><p><b>Candidate Profile</b></p><ul><li>A master’s degree in life science, pharmacy, or similar</li><li>Several years of experience with GMP operations in the Pharmaceutical Industry</li><li>Experience with Quality Assurance work with commercial medicinal products.</li><li>Lead auditor training and experience within GMP area will be preferred</li><li>The ability to qualify as a Qualified Person delegate.</li><li>Result oriented mindset and have a track record in reaching compliant solutions with a team based and approachable attitude</li><li>Excellent communication skills both verbally and in writing</li></ul><p></p><p><b>Bonding to innovate ​</b></p><p>Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.​</p><p></p><p>Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.​</p><p></p><p>We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise. ​</p><p></p><p>We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.​</p><p></p><p>The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.​</p><p></p><p><b>Let’s bond and be bold ​</b></p><p>We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities.<br/> </p><p>Interested? Please apply no later than January 20, 2025, or as soon as possible. The applications will be reviewed as they come in.<br/> </p><p>For further information, please contact Johan Rose on <a href="mailto:jrose@zealandpharma.com" rel="noopener noreferrer" target="_blank"><span>jrose@zealandpharma.com</span></a>.</p><p></p><p><b>About Zealand Pharma A/S </b></p><p>Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to r