Posted : Sunday, April 14, 2024 09:34 PM
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals.
Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally.
From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.
The Opportunity Lead the QA operations team to drive the quality improvement and new product introduction objectives for Dechra Melbourne ensuring customer and regulatory requirements are met for all product types and markets.
Including leads change projects, and upskilling other teams to support this plan.
Ensure the batch release process and site quality systems are in compliance with marketing authorisations and FDA guidelines.
Work with the other Dechra Melbourne Teams to support customer challenges, always providing an effective solution to our customer’s problems every time.
To coach and mentor the QA operations support team as part of their personal development.
Main Responsibilities So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including: Provide strong leadership of the quality team and ensure a strong factory floor presence within the Manufacturing and Packaging areas Build and encourage positive relationships across the site functions to ensure support and collaboration in raising quality standards Design, develop, and implement a sustainable quality strategy for the site.
Plans should include any resource, system, or investment required with clear milestones to demonstrate progress Ensure quality risk management activities are implemented and enable identification, mitigation, and/or escalation of risks for items that could adversely impact quality compliance associated with projects/systems Ensure the Quality function operates aligned to the 5 strategic pillars across the site and wider DPM&S division (People, Safety, Quality, Delivery & Cost) Support the development of the quality team by mentoring and coaching team members to improve their knowledge and secure succession plans To promote quality culture across the site by liaising with cross-functional teams To develop and manage the Quality team and provide coaching and mentoring on Quality Management Systems To manage internal and external audits, and support vendor quality management activities To focus on continuous improvement of processes.
Update procedures and policies as needed to maintain compliance and improvement To establish, track, and present Quality Metrics to support Quality Management Review To provide guidance for higher-level decisions required for change management and deviation investigations To lead regulatory agency inspections (e.
g.
FDA etc.
) To supply feedback to the SLT on any trends and serious quality issues or non-compliances that are detected by QA staff whilst carrying out duties for GMP and GDP activities To ensure adequate QA resources are available to deliver the agreed business targets To proactively influence management regarding the adoption of standards to improve quality, efficiency, and compliance within Dechra.
The Ideal Candidate Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life.
We’re particularly excited to hear from those who have/are: Experience in the Pharmaceutical or Food Supplement industry with management experience Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience of auditing/inspection techniques, including internal process/system and documentation audits, as well as experience with related quality assurance principles applicable to pharmaceutical manufacturing Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related A formal qualification in quality assurance/quality management in a regulated pharmaceutical environment Previous people leadership experience preferred Previous experience working with FDA and participating in regulatory agency inspections Previous experience of project management, time management and people management About The Company As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements.
We offer a generous employer 401k match and an employee stock purchase plan for long-term financial wellness.
Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals.
Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally.
From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.
The Opportunity Lead the QA operations team to drive the quality improvement and new product introduction objectives for Dechra Melbourne ensuring customer and regulatory requirements are met for all product types and markets.
Including leads change projects, and upskilling other teams to support this plan.
Ensure the batch release process and site quality systems are in compliance with marketing authorisations and FDA guidelines.
Work with the other Dechra Melbourne Teams to support customer challenges, always providing an effective solution to our customer’s problems every time.
To coach and mentor the QA operations support team as part of their personal development.
Main Responsibilities So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including: Provide strong leadership of the quality team and ensure a strong factory floor presence within the Manufacturing and Packaging areas Build and encourage positive relationships across the site functions to ensure support and collaboration in raising quality standards Design, develop, and implement a sustainable quality strategy for the site.
Plans should include any resource, system, or investment required with clear milestones to demonstrate progress Ensure quality risk management activities are implemented and enable identification, mitigation, and/or escalation of risks for items that could adversely impact quality compliance associated with projects/systems Ensure the Quality function operates aligned to the 5 strategic pillars across the site and wider DPM&S division (People, Safety, Quality, Delivery & Cost) Support the development of the quality team by mentoring and coaching team members to improve their knowledge and secure succession plans To promote quality culture across the site by liaising with cross-functional teams To develop and manage the Quality team and provide coaching and mentoring on Quality Management Systems To manage internal and external audits, and support vendor quality management activities To focus on continuous improvement of processes.
Update procedures and policies as needed to maintain compliance and improvement To establish, track, and present Quality Metrics to support Quality Management Review To provide guidance for higher-level decisions required for change management and deviation investigations To lead regulatory agency inspections (e.
g.
FDA etc.
) To supply feedback to the SLT on any trends and serious quality issues or non-compliances that are detected by QA staff whilst carrying out duties for GMP and GDP activities To ensure adequate QA resources are available to deliver the agreed business targets To proactively influence management regarding the adoption of standards to improve quality, efficiency, and compliance within Dechra.
The Ideal Candidate Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life.
We’re particularly excited to hear from those who have/are: Experience in the Pharmaceutical or Food Supplement industry with management experience Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience of auditing/inspection techniques, including internal process/system and documentation audits, as well as experience with related quality assurance principles applicable to pharmaceutical manufacturing Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related A formal qualification in quality assurance/quality management in a regulated pharmaceutical environment Previous people leadership experience preferred Previous experience working with FDA and participating in regulatory agency inspections Previous experience of project management, time management and people management About The Company As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements.
We offer a generous employer 401k match and an employee stock purchase plan for long-term financial wellness.
Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
• Phone : NA
• Location : Melbourne, FL
• Post ID: 9004194840