Vice President of Regulatory & Quality

JOB DESCRIPTION

We are looking for a superb leader to drive the vision, strategy and management for our Quality Assurance and Regulatory Affairs department. Your responsibilities will include building and aligning business strategic objectives and the quality management process for the organization.

Your strong leadership ability and excellent managerial skills will motivate, develop, and retain a high performance Quality department.

This position will include interfacing effectively with internal personnel, clients, and auditors, including the FDA and all other regulatory agencies and you will be responsible for preparing the proper response to any observation.

As head of our quality department, you will have full responsibility for all QA/QC functions, including but not limited to document control, finished product release, QC, internal/ external audits, as well as personnel training records.

Your in depth knowledge and experience authoring and contributing to CMC sections for regulatory sections of ANDA’s, NDA’s and IND’s will enable Avrio to achieve company and clients expectations.

Your decision-making and analysis of multiple factors in matters involving very complex issues, will help to drive the company to high quality standards surpassing company /client expectations.

REQUIREMENTS

Requires a B.S./M.S. (Ph.D. prefer) with minimum 15+ years of working experience in pharmaceutical, or biotech industry in a regulatory/quality assurance role, with experience in the contract Manufacturing industry (CMO) highly preferred.

Recent parenteral, aseptic fill/finish experience required. Experience working in a pharmaceutical or biopharmaceutical service orientated company.

Proven track record of success as a Director RA/QA, or Senior Director RA/QA.

Excellent written, verbal, and communication skills. Demonstrates strong in-depth clinical, technical and scientific knowledge.

Avrio Biopharmaceuticals, is dedicated to building a world class Quality organization. If you believe you have the experience, knowledge and knowhow to lead and build our Regulatory/Quality team, we would like to hear from you!