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Director, Quality and Regulatory Affairs- Biomaterials North America

Job Category:  Quality
Work Location:  Corbion Site
Office Location: 

Tucker, GA, US

Job Type:  Full Time
Job ID:  920

Corbion develops sustainable solutions to improve the quality of life for people today and for future generations.

 

Corbion (formerly known as Purac Biomaterials) is the market leader in providing high quality resorbable polymers in the field of medical devices and pharmaceutical applications. These resorbable polymers are used in orthopedic implants, drug delivery systems and surgical suture applications among others. Corbion is now hiring a Quality and Regulatory Affairs (QRA) Director to join the company in its manufacturing facility in Tucker, GA, USA.

 

Position Summary:

The QRA Director Biomaterials is responsible for all quality and regulatory activities of products produced at the Biomaterials manufacturing facility in Tucker, GA. The QRA Director is part of the local management team, that reports into the General Manager, and works closely with the QRA Director Biomaterials in the Netherlands and the Biomaterials global leadership team.

 

Responsibilities:

  • Execute the QA/RA policy, including quality policy (ICHQ7 & ISO) and product registrations at the FDA and other regulatory authorities, in line with the strategy and ensure compliance with global regulations for the pharmaceutical and medical device industry
  • Lead and manage the quality departments (QA, QC, and regulatory)
  • Management representative for quality in the local Biomaterials management team
  • Responsible for procedures or specifications affecting product quality and final approval or rejection  of finished batches of product to the market.
  • Formulate and recommend quality policies and programs that guide the organization in maintaining and improving the quality department
  • Responsible for adequate design and control of the quality management system
  • Host external audits including customer audits, regulatory audits, and quality-system certification audits.
  • Maintain adequate and successful communication with related authorities, suppliers and service providers

 

Minimum Qualifications:

  • Master degree in science or other relevant area
  • 10+ years of experience in a quality manager role in a pharmaceutical or medical device company or a company supplying to these industries, including hands-on experience in batch record review, disposition, and validation
  • Prior experience  working with regulatory agencies, including FDA audits and filings
  • Proven knowledge and experience with FDA CFR 21, ICH Q7, ISO 9001, ISO 14971, and ISO 13485, cGMPs as well as cGLPs
  • Experience leading quality departments of companies supplying to several different medical and pharmaceutical end markets with different QRA requirements, preferred
  • Proven leadership qualities in developing teams and building and managing relationships both internally and with business partners as well as experience building strong quality culture
  • Ability to prioritize and align the organization with goals and objectives
  • Ability to travel overnight occasionally

 

About Corbion

Corbion is the global market leader in lactic acid, lactic acid derivatives, and a leading company in emulsifiers, functional enzyme blends, minerals, vitamins and algae ingredients. Our sustainable ingredient solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. With a worldwide network of production facilities, sales offices and agents in more than 100 countries, Corbion is known for quality, product innovation, and customer orientation, as well as for its collegial, informal and results-oriented company culture.

 

Corbion is an equal opportunity employer and committed to a diverse workplace.  All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors.

 

Corbion provides reasonable accommodation to applicants with disabilities.  If you need a reasonable accommodation for any part of the application and hiring process, please notify the Corbion Human Resources department.  The decision on granting reasonable accommodation will be on a case-by-case basis.

 

EOE/M/F/Vet/Disabled

 

Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.


Nearest Major Market: Atlanta

Job Segment: Medical, Orthopedic, Quality Manager, Pharmaceutical, Healthcare, Quality, Science

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