Head of QC Finished Products & Stability (all Genders)

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‚Health for all, Hunger for none‘ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Head of QC Finished Products & Stability (all Genders)

As the Head of QC Finished Products & Stability (all genders), you are accountable for the strategic development and implementation of the following core areas to ensure compliance with GMP guidelines and standards as well as Bayer’s global cGMP requirements, and to secure the operating license of Bayer Weimar GmbH & Co. KG and Bayer AG.

YOUR TASKS AND RESPONSIBILITIES

• Quality Control Strategy: You will be accountable for design, plan, and implement a cGMP-compliant quality control strategy as well as stability testing in accordance with AMG, pharmaceutical operations regulations, as well as international guidelines and pharmacopoeias.
• Stability Monitoring: You monitor the stability of finished pharmaceutical products by organizing and coordinating stability studies, including their scientifically grounded evaluation.
• Life-Cycle Management: You are accountable for the life-cycle management of analytical test methods, analytical equipment, and raw data documentation.
• Process Optimization: You strategically develop and continuously improve operational QC processes while ensuring environmental and accident protection as well as occupational safety.
• Regulatory Documents: You create and maintain product documents, Technical Regulatory Documents (TRDs), and global regulatory dossiers, such as for product license applications and approvals.
• Expertise and Reports: You prepare expert opinions and reports on the pharmaceutical quality and stability of finished pharmaceutical products, as well as on the evaluation of adverse drug reactions and complaints, insofar as they affect the pharmaceutical quality of the products.
• Team Development: As a leader, you promote team development and drive close collaboration and open exchange with other quality units within the network.
• Expert Knowledge: You provide expertise, services, and problem-solving skills for site operations and within the Bayer network.

WHAT YOU BRING

• You have a completed university degree in Chemistry, Pharmacy, or other natural sciences (PhD preferred).
• You possess specialized knowledge in chromatography, spectroscopy, and the use of computer-assisted analytical instruments.
• You have extensive professional experience (+10 years) in a GMP-regulated environment and proven experience in cross-functional leadership roles. You have in-depth knowledge of international regulatory requirements, cGMP, pharmaceutical standards, and pharmaceutical regulations.
• You bring extensive experience in preparing regulatory documents and addressing regulatory issues.
• You are capable of building trust and creating a psychologically safe environment to unlock the full potential of the team.
• You have strong partnering/stakeholder management skills across various business functions and locations.
• Excellent team player with experience and skills in change management.
• You possess strong analytical thinking and problem-solving abilities with clear decision-making, a high level of commitment, and the ability to work under pressure.
• Excellent communication skills in both German and English, both written and spoken.

The position holder (all Genders) demonstrates, embodies, and credibly presents the leadership role of VACC by acting as:

Visionary: Guiding teams in defining outcomes to fulfill the mission.

Architect: Designing a value-adding system to unleash the passion and energy of our employees.

Catalyst: Removing obstacles to facilitate connections and collaboration.

Coach: Helping teams learn and build the skills they need to create value for customers and stakeholders.

Dynamically assigning talents with the right skills to customer, product, and design teams based on business needs and defined outcomes.

WHAT WE OFFER

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: What matters to you, matters to us!

• We ensure your financial stability through a competitive compensation package, consisting of an attractive base pay, our performance based company bonus and a global, equity-based cash plan with a four-year duration. In addition, managers can recognize special contributions by granting an individual performance award or top performance award.
• Your family is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more.
• We support your professional growth by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs.
• We promote health awareness and opportunities for self-care through various measures, such as free health checks with the company doctor and our health platform #machfit.
• We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work.

Be You. Be Bayer.
#LI-AMSEMEA

YOUR APPLICATION

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Location: Germany : Thuringia : Weimar

Division: Pharmaceuticals

Reference Code: 835054

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