Quality Assurance 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

Maintain and improve the Quality Management Systems within Dechra Pharmaceuticals Manufacturing Pomona, CA site. Promote, develop and oversee compliance of company quality system as it related to drug product manufacturing and release. Effectively assuring compliance of customer requirements by managing quality policies, standards, procedures, programs and practices while driving and facilitating continuous improvement.

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:

• Bachelors Degree in Chemistry, Biology or related science is preferred.
• Minimum of five (5) years of experience working in a Pharmaceutical GMP environment.
• Minimum of five (5) years of experience in a QA and/or QS role in a pharmaceutical manufacturing environment.
• Proficiency in Microsoft Office particularly in Excel, PowerPoint, and Word. LIMS systems and ComplianceWire experience is a plus.
• 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.
• 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.

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