Head of QA Systems & Operations Development

QA Operations in Product Supply, Bayer AS, is a key contributor to Bayer’s performance as a quality compliant partner and worldwide supplier of radiopharmaceutical products, covering both commercialized products and products under development. Being the Lead Function for radiopharmaceuticals in Bayer we have the responsibility for Quality Oversight of our Contract Manufacturing Sites (CMOs) and is the release site for our commercial product. Close cooperation with international Bayer teams and the CMOs is a success factor. The development of our new products is organized in dedicated, global technical development teams and currently we focus on a platform for a broad range of new radiopharmaceutical products.

We are looking for a candidate with a professional attitude, strategic focus and good leadership skills. The candidate is highly experienced with management of quality systems and functions, including knowledge of pharmaceutical quality requirements and product release responsibilities. The successful candidate will lead and practically contribute to develop the QA processes and enable the QA team to reach the strategic goals of Bayer AS in a digital future, keeping the high quality level and good relationship and collaboration with our internal and external QA partners.

YOUR TASKS AND RESPONSIBILITIES:

• Be responsible for end-to-end Quality Oversight for our radiopharmaceutical product portfolio
• Lead QA team to
  • support internal Bayer teams and external partners in adherence of applicable GxP regulations in product development, manufacturing and logistics operations
  • perform Quality Oversight of our contract manufacturing partners, such as release, change management, deviation and complaint handling, CAPA follow up
• Establish or facilitate product release process for clinical and commercial products internal or at CMOs
• Represent voice of Quality and Compliance in all product and process related decisions to assure quality and compliance
• Provide quality requirements and standards to our Operations and product development teams and to our contract manufacturing partners in line with external regulations and internal Bayer quality standards and align QA activities globally
• Continuously develop our Quality Management Systems focusing on digitalization, keeping sustainable compliance level according to external regulations and internal Bayer quality standards
• Monitor Quality along supply chain for Bayer AS and respective products by Quality Management Reviews for Bayer AS and contract manufacturing partners, PQR/APR, Continuous Process verification

WHO YOU ARE:

• Master in (bio) chemistry, pharmacy, biotechnology, radiochemistry or similar education. In depth knowledge in development or manufacturing of radiopharmaceuticals will be of advantage
• Several years of experience in international biopharmaceutical/pharmaceutical industry or an equivalent combination of education and experience
• Leadership experience in a Quality environment in manufacturing or development of pharmaceutical or biotech products
• Strong interpersonal and leadership skills, high interest in and ability to achieve results through your team
• Excellent knowledge of cGMP requirements and Quality Management processes
• Demonstrated experience and competence working with cross-functional and multi-cultural teams, including experienced in working with international teams or external partners
• Experience with/strong interest in establishment of innovative and digital solutions
• Ability to troubleshoot critical issues or problems and resolves routine issues using appropriate information
• Forward leaning and seeking continuous improvement to support our strategic objectives
• Willing to travel as required
• Fluent in English, both written and spoken

Workplace is Lysaker, Norway. We can offer positive work environment at our nice offices at Lysaker. In addition to competitive benefits we can also offer good development opportunities.

Application Process:

Please apply and upload your CV and motivational letter as soon as possible, no later than April 5th 2021
Use the link in this portal https://rekry.oikotie.fi/recruitment/application/o/52498/locale/en_US

The recruitment process is carried out in collaboration with the consulting company Borka Consulting AS. If you would like to find out more about this position before submitting your application, please do not hesitate to contact

Bayer:
Nina Aalen Dørre, Head of Quality & CMC Documentation, phone +47 97187705
Anita Sollie, HR Business Partner Norway, phone +47 90139715

Or to external recruiter Borka Consulting AS:
Cecilie Fraas Borka, phone +47 928 55 352 / cecilie@borka.no
Andre Borka, phone +47 908 31 871 / andre@borka.no