Quality Control Compliance 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 

The Quality Control (QC) Compliance Manager is responsible for providing support and leadership to analytical chemistry and microbiology laboratory operations and testing.  This role is required to lead the development, and implementation of compliance programs for the organization in addition to monitor QC activities to ensure compliance to applicable procedures, policies, and regulations. Additionally, the QC Compliance Manager is responsible for the QC laboratory investigations (Out of Specification, Deviations, Quality Events, CAPAs, etc.), QC instrumentation program, data review and audit readiness. This role will require full collaboration with analytical development, manufacturing operations, Quality Assurance, and Regulatory

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

• Leading the direct reports, providing hands-on guidance and support to ensure the team is successful in meeting their objectives. Proven ability to engage, motivate, and develop the workforce.
• Developing and implementing learning and development opportunities for team members to enhance their skills and abilities.
• Making informed scientific sound, quality decisions related to manufacturing and testing suspensions, ointments, liquids and pastes for topical, oral and Otic applications.
• Ensuring timely initiation and closure of documentation related to deviations & investigations, CAPAs, change controls, SOPs, with standardized supporting documentation. Identify gaps in practices, policies, and procedures
• In-depth understanding and adherence to Quality System Requirements established by Med-Pharmex. Provides continuous improvement for compliance and Quality systems.
• Prioritize and manage available system resources to ensure schedule adherence for quality reporting.
• Establishing and enforcing effective SOPs and training documents to promote consistency and compliance within the team.
• Responsible for ensuring QC compliance with all Federal, State, local and company regulations, policies, and procedures related to cGMP, Environment, Health and Safety practices. A SME representing QC Compliance during regulatory inspections.
• Responsible of Identify compendial changes  for laboratory compliance (i.e. FDA, ICH, compendial revisions and laboratory safety), practices, policies, and procedures. Demonstrates full understanding of routine laboratory procedures.
• Applies extensive technical expertise and has knowledge of other related business disciplines/processes.
• Work closely with Quality Assurance (QA) to support and ensure inspection readiness.
• May assist QC Chemistry team in performing data review of test results as needed.
• Leads, responsible and works closely with staff on QC’s OOS, OOT, deviation, abort/Invalid, quality event and/or CAPA investigations, reports, and root cause analysis for all testing that occurs within the Med-Pharmex and contract laboratory for cGMP production, studies, and investigations.
• Develop, maintain, and report statistical analysis and metrics of QC stability data.
• Inform laboratory management and Senior Management of adverse trends.
• Work closely with the QA Training and Compliance Specialists as needed to provide necessary technical support for the training program pertaining to the QC department.
• Responsible for cGMP tasks required throughout QC instrumentation lifecycle.
• Provide the support required for acquiring and qualification of new analytical instrument as needed.
• Ensure all QC analytical instruments and equipment is up to date on Preventative Maintenance and calibration activities.
• Support the development and execution of validation studies and projects.
• Assist in any investigations for health and safety related incidents.
• Perform and deliver year-end direct report’s performance reviews.
• Direct day-to-day staff activities including assignment of resources - supervise others as assigned.
• Facilitate and/or support Quality Control laboratory 5S; tour/audit readiness
• Establish and direct QC Laboratory in QC support activities for GMP manufacture that will include method transfer, in-process testing, analytical method validation, Drug Substance (DS) and Drug Product (DP) release testing, DS and DP stability studies, reference standard qualification, etc. utilizing HPLC, GC, FTIR, Atomic absorption, KF and UV-vis.
• Other duties may be assigned by senior leadership.

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, preferable in a scientific discipline. 
• Minimum of 5 years of Pharmaceutical Quality Experience.
• Minimum of 2 years of management experience.
• Excellent written, verbal, and presentation skills.
• Ability to deal effectively with all levels of the organization.
• Strong problem-solving skills.
• Strong leadership, performance management, and employee development skills.
• Excellent organization skills and the ability to multi-task and prioritize with minimal direction.
• Strong time management 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.