AbbVie

Dir Quality Medical Device

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Sep 13, 2020
Ref
202625
Discipline
Quality, Quality Control
Required Education
Masters Degree/MBA
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

Director, Quality Medical Device

What Your New Manager Wants You To Know

I am looking for an experienced Quality Director for Third Party Medical Devices for AbbVie with authority and responsibility for the effective operation of medical device quality function relating to third party manufactured products, leading a team responsible for the effective operation of the Medical Device QA function supporting notified body and MOH audits, Quality System Management Review and other Quality System activities as required for the life cycle of medical devices.

This role is required to support AbbVie's global corporate quality compliance systems (including Inspection Management, Management Review programs), regulatory agency readiness and filings within the quality management system. Provide troubleshooting quality compliance support to third party device manufacturers as well as product development and/or integration of new products into the Medical Device Quality system is line with AbbVie policies.

Sincerely,

Associate VP, Med Device Manufacturing

YOU ARE more than just a title, YOU ARE...

A strategic thinker : Align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player : Collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

Be responsible for commercial product Risk Management Review program which includes updates to RMFs as required (both 3rd party devices and AbbVie site manufactured devices).

All activities must be conducted in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Main Areas of Responsibilities
  • Supports product lifecycle Quality Risk Management for all 3rd party medical devices and where appropriate combination products within the AbbVie device portfolio.
  • Oversee management of all 3rd party device manufacturers as per requirements defined in each suppliers quality agreement.
  • Provide quality plan and support as required for any new AbbVie acquisitions to ensure an effective and compliant integration.
  • Be responsible for quality decisions related to all aspects of the medical device compliance and strategic direction. Ensure that medical device best practices for key quality operations are identified and standardized.
  • Participates as a QA member of the AbbVie team to ensure sound quality and compliance practices are incorporated into the overall strategic direction within the Product Lifecycle.
  • Lead, coach and mentor a team of quality professionals who are responsible for compliance and quality oversight of TP Devices and where appropriate internally manufactured devices.
  • Capable, and of appropriate experience and education to act as deputy management representative for medical device and combination products.
  • Coordinate and conduct all 3rd party supplier data into the Quality system management reviews. Coordinates and provides various subject matter expertise in preparation for MOH and Notified Body inspections and ensures inspectional responses are finished in a timely manner.
  • Host regulatory/ notified body inspections as appropriate.


Qualifications

You Bring
  • Excellent judgment and decision making capability in the technical and compliance arenas.
  • Excellent analytical, interpersonal and verbal/written communication skills, with both internal constituencies and external regulatory stakeholders.
  • Strong analytical and information retrieval skills
  • Integrity, judgment, and the ability to hold one's ground under pressure.
  • Ability to work in a multinational, multicultural and highly matrix environment.
  • Team player with strong customer orientation.
  • Ability to travel approximately 20% of the time.
  • Knowledge and experience in pharmaceutical and medical device product documentation procedures with proven ability or project experience in developing systems and business processes to improve overall efficiency and productivity.
  • Experience of trade association interaction
  • Ability to influence individuals that are outside the span of direct control (i.e., influence without authority).
  • Must have excellent Organizational Skills. Must be detail and quality oriented.
  • Proficient in computer skills and hands on experience in different computer software such as database management, spreadsheets, project management, presentations word processing flowcharting and/or any other similar type of programming.


Education
  • Education equivalent to a 4 year college degree, with an emphasis in a technical discipline such as Chemistry, Microbiology, Pharmaceutics or Biochemistry. Additional scientific training M.S., PhD, and/or MBA a plus.
  • Fifteen to twenty years of QA/QC/RA experience in pharmaceutical, medical device or combination product environment. Sound technical skills including working knowledge of pharmaceutical, medical device, or combination product manufacturing, CE Marking process, regulatory intelligence, regulatory submission support, quality assurance, and analytical testing technologies.
  • In depth knowledge and experience with device requirements for products in major markets around the world (FDA, Health Canada, Notifed Body,TGA, MHRA, MDD, ISO etc.). Experience with and ability to manage and influence regulatory agency personnel at all levels, both in field compliance and agency centers.
  • In depth knowledge and experience with quality systems, corrective action and preventive action system, statistical process control, field corrective action management, regulatory intelligence, auditing, and other key tools for managing global quality performance in the medical device and combination product arena.


Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.