QA Operations Sr. Manager - Dechra Pharmaceuticals PLC

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 Systems within Dechra Pharmaceuticals Manufacturing Pomona, CA site. Promote, develop and oversee compliance of company quality system asit 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.

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 oversee quality and ensure a strong factory floor presence within the Manufacturing and Packaging areas
• Perform batch record review, and disposition related activities for Drug Substance, Drug Product, Packaging and labelling.
• Perform review and approval of analytical and microbiological testing raw data for the Drug Substance and Drug Product.
• To promote quality culture across the site by liaising with cross functional teams
• To develop and manage the QA team and provide coaching and mentoring on Quality Manufacturing operations, record review, material and product release.
• To participate in internal and external audits, and support quality management initiatives  
• To conduct compliance risk assessments, trend analysis and provide recommendations for compliant business 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 provide support and participate in internal and external, and other regulatory agency inspections.
• To assist with the planning of required internal annual audits and other audits as needed and assigned
• To conduct training and coaching of the QA team members on the how to perform batch record review, documentation of findings, as well as review/evaluate adequate completion of all records requirements and via 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
• To liaise with auditors to 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 and disposition for supplies that are subjected to temperature excursion.
• Write and review Standard Operating Procedures.
• Write and approve 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    

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:

• Bachelor’s degree in Chemistry, Biology or related science is preferred.
• Several years of experience working in a Pharmaceutical GMP environment.
• 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.
• Several 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.

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.