Job Overview

Fabulous opportunity to join International Biotech firm on a growth trajectory in Director, Quality Operations position.  With a Pharmaceutical background, BioChemistry, Biology or related degree + 10 years’ experience, you will use your hands on approach to lead and mentor your team, scale up the department and build out quality systems.

Overseeing two sites and a department of 24, you will be responsible for the quality oversight of end to end processes relating to make, assess, and release of products. As Head of the Quality Team, you will be a member of the local leadership team and will support cross functional goals and objectives.

Responsibilities

You will:

• Regularly interact with senior management on matters regarding the state of the Quality Management System.  Develop and present continuous improvement goals and metrics related to Quality Objectives and processes to senior management during Management Review meetings.
• Mentor and coach direct reports and others in a team environment.
• Establish KPI metrics associated with continuous improvement and cost reductions.
• Evaluate Quality systems and processes to improve efficiency and throughput.
• Understand domestic and international Quality System Requirements and how they interact to be able to provide quality guidance to other departments.
• Review process data (e.g. product dispositions, deviation and non-conformance reports, etc.) to recommend and implement improvements.
• Develop systems and processes that increase product consistency and conformance to requirements; and improve operational efficiency.

Requirements

You have:

• BS in Biochemistry, Chemistry, Biology or similar with a minimum of 10+ years of experience and/or a MS with 6+ years related experience; or equivalent combination of education and experience.
• 8+ years’ experience in FDA 21 CFR part 820 and 210 and ISO 13485 regulated environment.
• Pharmaceutical Quality Management Systems ICH Q7 experience.
• A minimum of 6 years management experience in a regulated industry.
• Proven leadership and communication acumen with a demonstrated ability to coach and mentor staff to achieve desirable results.
• Multi-site QMS leadership experience required with International QMS leadership preferred.