Manager QA Mammalian

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Manager QA Mammalian
QA Mammalian team is expanding and is looking for a manager in QA operation.

Are you passionate about leading teams to success? We are seeking a dedicated and passionate Quality Assurance Manager to join our dynamic team at AGC biologics. If you have a knack for ensuring products meet high-quality standards and enjoy guiding and motivating a team to best, we want to hear from you!

About the Team // The department
QA Operations consists of two sub teams with the main responsibility of quality assurance of manufacturing activities and batch release of microbial and mammalian recombinant manufacturing of drug substances (API) and cell banks.

AGC Biologics is a CDMO and covering international pharma customers. We manufacture a wide range of drug substances from clinical to commercial projects.

The QA mammalian team consists of scientists and principal scientists with various professional backgrounds and years of experience. You will be reporting to Senior Manager for QA mammalian team.

The department has an open communication with a focus on a high level of professionalism. We are open-minded and have a high service level for our colleagues in the rest of the AGC Biologics organization - and not least for our international customers. The QA Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

We actively work within our field of understanding- and interpreting legislation to ensure manufacturing is in compliance with current standards for GMP production, i.e., EU GMP, 21 CFR and ICH guidelines. Continuously we improve our standards within quality- and manufacturing processes, innovate with modern technology and our common value chain with internal stakeholders.

The Role/daily responsibilities:

• Lead the QA mammalian team, providing guidance, support, and mentorship to team members, to include regular one to one meetings and continuing development conversations.
• Develop and implement quality assurance processes and procedures to ensure products meet established standards and customer requirements.
• Oversee product release plans and inspection activities, ensuring accuracy, completeness, and timeliness.
• Management and oversight of quality records associated with the manufacturing processes, e.g deviations, change controls, manufacturing production record approvals,
• Identify areas for improvement in quality processes and drive continuous improvement initiatives.
• Collaborate with cross-functional teams to address quality issues and implement corrective actions.

Your Profile:
As a person you possess a proactive attitude, striving for a higher performance and embracing challenges from peers and employees.

Join us and be part of a supportive team environment where your skills and expertise will be valued and recognized. If you are ready to take on a leadership role in quality assurance and drive excellence in our products.

Education and experience:

• A minimum degree in a Science-related field (e.g., Pharmacy, Biology, Biotechnology Science), coupled with substantial experience in QA or manufacturing.

• Proven within a leadership or supervisory role from a pharmaceutical company.
• Strong knowledge of quality management principles, methodologies, and tools.

• Excellent leadership and team management skills, with the ability to inspire and motivate team members.
• In-depth knowledge of GMP principles and guidelines in manufacturing.
• Exceptional communication skills, both written and verbal, to engage effectively with internal and external stakeholders.
• The ability to navigate a fast-paced, matrix environment, juggling deadlines and tasks with finesse.
• Flexibility to adapt to evolving business needs and priorities.

AGC has international customers, and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Location: Copenhagen Site