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QA QMS, Senior Manager

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.

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 

**Insert overview here**

Role Responsibility

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

  • To promote quality culture across the site by liaising with cross functional teams
  • To develop and manage the QA QMS team and provide coaching and mentoring on Quality best practice and procedures, record review and regulatory requirements.
  • Oversee and assist with implementation and training of new quality processes, and support quality management initiatives.  
  • To conduct compliance risk assessments, trend analysis and provide recommendations for compliant business activities.
  • Oversee the Supplier Quality Management program, Training, Enterprise systems VEEVA and Delphi, LIMS and Document Control.
  • Ensure only adequate/approved suppliers and vendors are utilized by the company. To establish, compile, track, and present Quality Metrics to support Quality Management Review
  • To provide guidance for higher level decisions required for change management and CAPA programs.
  • To provide primary support, planning and participate in internal and external, and other regulatory agency inspections ensuring compliance to procedures and author responses.
  • Monitoring industry inspection trends, regulations and guidance’s for impact to programs and operations
  • Work with department heads to establish and maintain data integrity initiatives.
  • To conduct training and coaching of the QA team members on the how to perform review, documentation of findings, as well as review/evaluate adequate completion of all records requirements with supporting documentation.
  • To supply feedback to the Head of Quality and 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.
  • Ensure that the CAPAs resulting from audits associated with the assigned programmes and studies are allocated a CAPA owner and closed out appropriately and in a timely manner.
  • Perform impact assessment supporting disposition decisions for product and raw materials in conjunction with site procedures and investigations.
  • Write, review or Approve Standard Operating Procedures, and internal investigations, as applicable.
  • 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 keen to hear from those who have/are:

  • Manages QA personnel, including organizing and prioritizing daily activities, training, and performance reviews.
  • Proficiency in Microsoft Office particularly in Excel, PowerPoint, and Word.  LIMS systems and ComplianceWire experience is a plus.
  • Bachelor’s degree: Degree in Chemistry, Biology or related science is preferred.
  • Solid experience working in a Pharmaceutical GMP environment.
  • Exceptional experience in a QA and/or QS role in a pharmaceutical manufacturing environment.
  • Advanced knowledge of Quality Management Systems operations policies, procedures and management and tracking of Quality Metrics.
  • Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance.
  • Lean, Six Sigma and cGMP experience preferred.
  • Must have Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and work effectively in a multi-disciplinary team.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
  • Ability to multi-task, set priorities and meet strict deadlines.
  • Develop, implement, and manage processes to ensure products meet required specifications for quality, safety, and efficacy.
  • Set appropriate quality standards and parameters for products.
  • Communicate quality standards and parameters to the quality assurance and manufacturing groups, and other relevant staff.
  • Ability to lead, motivate, coach, and teach others.
  • 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.
  • First class organisational skills
  • Ability to prioritise, demonstrating good time management skills.
  • Self-motivated, with the ability to work proactively using own initiative.
  • Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience of related quality assurance principles applicable to pharmaceutical manufacturing.
  • Strong organizational skills and the ability to multitask.    
  • Demonstrated ability in working independently and as part of a team.
  • Excellent communication (oral and written) and interpersonal skills.

 

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 competitive salary packages for 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 Pharmaceuticals PLC

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