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Ferring Pharmaceuticals

Global QA Senior Manager, Medical Devices & Drug/Device Combined Products

Kiel
Posted about 22 hours ago
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Job Description

At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology.

Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world. Our Technical Operations division develops, manufactures and supplies high-quality products so our patients can live better lives. Creating and delivering life-changing products means getting it right first time is a shared responsibility, so our global manufacturing teams work closely together to ensure quality, accuracy and safety at all times. That means a culture of empowerment, where speaking up is valued, and growth and development are constant.

Ferring+You

As Global QA Senior Manager, Medical Devices & Drug/Device Combined Products, you will lead Major Global QA Medical Device projects, and you will support the Ferring Manufacturing sites as main point of contact regarding Medical Devices and device constituents of combination/medicinal products. The role may require travel of approximately 10–20% of your time, mainly within Europe.

Your day at Ferring

As part of the Global QA Medical Device Organization, you will:

  • Contribute to QMS improvements for medical device and device constituent of combination products and support ISO 13485, MDSAP & MDR certification.
  • Own key Medical Devices Process/SOPs.
  • Ensure the corporate QMS for device activities at Manufacturing Sites, in Operation and in Central functions is implemented.
  • Support the Manufacturing sites dealing with Medical Devices and Combination Products (by providing guidance, coordination and escalation on topics such as complaints, Deviation/CAPA, Change Request, vendor assessments or during audits Notified Bodies, FDA and Competent Authorities).
  • Support the Commercial Medical Devices/Combination Products Projects as QA representative, ensure inputs from sites are considered and transfer properly organized.
  • Lead assigned GQA Projects and audits.

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Behind our innovation…There’s you

Nice to have a scientific degree, preferably Master (pharmacy, chemistry, biology or equivalent). 10 years of experience in the Pharmaceutical and Medical Device Industry (development, manufacturing, packaging, QC, QA) and cGMP environment or equivalent. Standards such as 21 CFR part 4, part 820, MDR and ISO13485 regulations (MDSAP is a plus). Design control / Design & Development process for Medical Devices and Drug/Device Combination product, Experienced in Project Management. Vendors/Customers relationships and you have the ability to set up links between external and internal partners. Medical Device / Durg Device Combination Product company auditing (as a lead auditor).

You are accountable, collaborative and entrepreneurial, with a curious mindset.

People come first at Ferring

Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love. Our inclusive support package – “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role.

Subject to a minimum period of employment at Ferring. Subject to a minimum period of employment at Ferring.

  • Parental leave for both birthing and non-birthing parents.
  • Extended support on family building journey.

Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions.

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Imagine the power of your career when it’s Ferring + You.

Behind our purpose… There’s you

If our mission and your vision are aligned, please apply! We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.

Note to agencies: this search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us spontaneous profiles.

Location

Ferring Controlled Therapeutics UK

Ferring Pharmaceuticals a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries.

Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X.

At Ferring, we'll give you the tools to shape a career build on purpose. Join us and help People around the world to build families and live better lives.

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At Ferring, our focus on Patient Advocacy drives our commitment to create more equitable health outcomes for all, at every stage of their healthcare journey. We believe in everyone’s right to access the best treatment, pioneering into new therapeutic areas, and developing innovative ways to diagnose, treat and prevent diseases.

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Skills

Quality Assurance
Medical Device Regulations
ISO 13485
MDSAP
MDR
21 CFR Part 820
21 CFR Part 4
Project Management
Design Control
Auditing
CAPA
QMS Improvement

Location

Kiel, Schleswig-Holstein, Germany

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