Quality And Technical Operations Remediation Lead

Job Introduction

Med-Pharmex Pomona Manufacturing is striving to improve GMP compliance. Working with Dechra Divisional experts, consultants and the Med-Pharmex Pomona leadership team, this role will lead and drive the FDA Consent Decree Remediations programme to ensure the improvement initiatives are delivered on time.

The role is open to candidates based in Los Angeles but we are also open to applicants looking to relocate to California.

Occasional travel will be required in the role.

Main Responsibilities

• Working with Head of Quality, conduct compliance risk assessments, trend analysis, provide and communicate recommendations for compliant business activities to senior management
• Building best practices, skills, and capability throughout the site organization, with a focus in the Operations, Supply Chain and MS&T (Manufacturing, Science and Technology) functions
• Prepare and present project update reports to senior management as required
• Working with regulatory affairs to understand, interpret and agree on suitable CMC submission strategies for the life-cycle management of approved products.
• Apply pharmaceutical operational and quality knowledge to highlight inter-process, systems and capability relationships and related activities that require improvement
• Review current practices and advise on appropriate strategies for product manufacturing and lead projects to implement improvement that ensure continuity of supply
• Management and execution of sustainable performance improvements
• Lead medium and large scale site based projects to improve efficiency, quality and compliance, with equal focus
• Apply practical problem solving to liquid, creams and ointments manufacturing processes

The Ideal Candidate

• Previous experience working with FDA and participating in regulatory agency inspections
• Experience with operational excellence, Six Sigma and continuous improvement methodologies
• Extensive experience in quality, manufacturing or MS&T departments of a commercial pharmaceutical manufacturing company
• Proven delivery of large to medium scale CMC projects involving manufacturing, quality, supply chain and regulatory affairs in support of commercial products
• Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related)

About The Company

Dechra is a global specialist veterinary pharmaceuticals and related products business. Our expertise is in the development manufacture and sales of high quality products exclusively for veterinarians worldwide. We are driven by our purpose of the sustainable improvement of local animal health and welfare.

We continue to grow because we understand the challenges veterinarian face. We provide training, support and information that helps them help animals. Accessible science that enables vets to communicate with owners and farmers better. It’s this perspective that makes us a preferred supplier. Understanding customers is built into our business model. We give veterinarians what they need, from everyday evidence-based treatments to knowledge on rarer diseases.