Qp & Ass. Director, Quality (M,F,X)

Are you an experienced Quality Professional in the pharmaceutical sector looking for a challenge? At Myonex GmbH we are seeking an Ass. Director, Quality who is also QP (m/f/x) as our new teamlead in Berlin.

About Myonex:

Myonex is a leader in providing integrated clinical and commercial services to support the advancement of life-saving medicine.

We partner with pharmaceutical, biotechs, and contract research organizations (CROs) in both clinical and commercial stages, including companies managing advanced therapies. With locations in the US, Germany, UK and France, Myonex supports projects globally.

Since 2022, Myonex Berlin is our Germany facility. With a long-standing experience in primary/secondary packaging and small batch-size IMP manufacturing capabilities, the Berlin facility brings expert and flexible support to early-stage clinical trials.

As our reach stretches further around the world, we are looking for a Qualified Person and Associate Director, Quality to take charge of our Quality Department in Berlin.

Location Benefits:

• permanent full-time contract (40-hour work week) - Please note that this is an office-based role with limited options for working from home
• Competitive salary dependant on experience
• Performance-related annual bonus
• 29 days of holiday plus national holidays
• Pension scheme
• A friendly and helpful team and office culture

About the Role:

As the QP & Associate Director, Quality you are Head of Quality Assurance & Quality Control and responsible for leading the Berlin Quality team to ensure that German Myonex site operates in compliance with local regulatory requirements as well as customer expectations. As Qualified Person (QP), you are responsible for certifying the batches of medicinal products before they're used in clinical trials or available on the market, oversee all aspects of the manufacturing process and ensure that each batch has been manufactured and checked in compliance with EU GMP, ICH guidelines and applicable German legislation, following the requirements of the marketing authorization (MA), the Investigational Medicinal Product Dossier (IMPD) and the trial protocol prior to release.

About the Candidate:

• Qualified according to EU directive as defined for QP and recognized as a Qualified Person according to § 14 AMG

• A recognized university degree in a health-related or pharmaceutical discipline (e.g., pharmacy, chemistry, pharmacy, medicine, biology, or a related scientific field).

• Minimum experience of 7 years in managing a team of people in a relevant process intensive, regulated environment required.
  
  Note: Full professional proficiency in both English and German language is required for this role.

• Strong knowledge of regulatory requirements including Good Manufacturing Practice, Good Distribution Practice, and Wholesale Distribution regulations and the ability to apply them to common sense, robust business scenarios.

• Pharmaceutical industry, pharmaceutical contract service organization or pharmaceutical distribution experience is required including experience in relevant German & EU laws (AMG, AMWHV, GDP, GCP-V, GMP/ICH Guidelines)

• Experience of working with the Regulatory Agencies.

• Knowledge of the investigational medicinal product supply chain is a plus.

• Ability to work with cross-functional/disciplinary teams.

• Demonstrated leadership leading successful Quality teams and implementing/maintaining a strong culture of quality.

  
  

Most important of all, your values will align with ours: you will Be a Great Team Player, Be Client Focused and you will always strive to Learn & Grow and Find a Way. Join us at Myonex and contribute to our mission of delivering excellence in the clinical trials space.

We are a fast-growing organization with big ambitions… if this sounds like something you would like to be a part of, get in touch!

Myonex is committed to ensuring equal opportunity in all aspects of employment. We do not discriminate against anyone on the basis of race, religion/creed, color, gender identity, sexual orientation, marital status, pregnancy, national origin, ancestry, military status, disability or perceived disability, use of a guide or disability support animal, or membership in any other protected class as defined by applicable laws and regulations. If an employee or applicant feels they have not received equal or fair treatment, we encourage them to contact Human Resources.

To find out more about what Myonex do and who we are as an employer, head to our LinkedIn page and website.