AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Quality Manager, Combination Products and Medical Devices - (all genders) - full time, unlimited
Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You’ve found the right place!
As part of our Research and Development team, you will be contributing to finding solutions and helping pave the way for innovative therapies that address complex diseases using innovative research approaches and state-of-the-art technology.
Further develop your expertise and join our team as
Quality Manager, Combination Products and Medical Devices (all genders) - full time, unlimited
Make an impact:
- Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.
- Perform design control activities: Mentor/lead product team members through the design process providing guidance to assure optimal approach. Work closely with research organization to ensure potential product issues are identified and addressed in the design. Assure robust product vs. customer requirements.
- Ensure interfaces to drug development where appropriate.
- Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the combination product/device.
- Analyze and justify the impact on cumulative changes
- Perform 3rd party supplier management activities such as review and approval of 3rd party design control activities, assess supplier changes and ensure of appropriate balance between internal oversight actions and supplier controls, provide input to quality agreements, perform relationship development, and visit supplier sites. Support supplier audits as required. Partner with Third Party Vendors/Manufacturers/Laboratories to ensure that combination products/devices are in compliance with internal and Regulatory Agency standards
- Risk Management: Global collaboration with R&D and Commercial Operations functions to identify and mitigate product risks to develop robust combination products and medical devices
- Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
- Guide project development as team member in global and local product development teams for Combination Products to proactively and appropriately address quality-related issues. Advise internal business partners with regard to medical device/combination product regulations
- Provide consultation & training on specific QA expertise to internal and cross-functional groups
- Foster close global collaboration with R&D and Operations functions to identify and mitigate product risks to develop robust combination products and devices. Perform risk assessment of changes on safety and efficacy of Combination Products. Utilize risk control tools such as FMEA
- Support the preparation of regulatory inspections and internal audits and represent GMP QA in inspections and audits as SME
This is how you can make a difference:
- Bachelor's degree is required; preferably in sciences, engineering or other technical/scientificarea.
- Minimum 6+ years of industry experience in Quality Assurance, Development or healthcarerelated field. Medical device experience required. Combination Product and 3rd party suppliermanagement experience preferred. Less experience considered with advanced degree.
- Understanding of regulations and standards affecting combination products and medical devicesrequired. Must have leadership skills and have been seen to take a position on Quality issues andstandards, and must be capable of clearly and logically justifying such positions.
- Sound technical understanding of product development (e.g. approaches for definition ofrequirements and specification setting for verification and validation) and/or practicalexperience in design control.
- Well-versed in risk management methodologies and their application.
- Able to take the initiative to identify and implement new approaches to resolve problems, able tochallenge scientific arguments - strong analytical approach to identify problem areas and effectivesolutions.
- Work independently and in a global team environment, and with all levels of personnel within theorganization.
What we offer you:
- a diverse area of work where you can make a real difference
- an open company culture
- attractive remuneration
- intensive onboarding by a mentor
- flexible work models for a healthy work-life balance
- corporate health management with comprehensive health and exercise programs
- corporate social benefits
- diverse career options in an international organization
- high-level, attractive career development opportunities
- a strong international network
At AbbVie, your individual contributions count – help us achieve more together. Be a part of it and grow with us – go above and beyond!
Sounds like the perfect career opportunity for you? We look forward to receiving your application.All you need is a complete CV – anything else will be discussed in person, where possible, if general suitability is determined.
Have questions? Email us atTalentAcquisition.firstname.lastname@example.org – we look forward to hearing from you!
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Travel: Yes, 5 % of the Time
Job Type: Experienced
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