Quality Control Chemistry Director

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

The Quality Control Chemistry Director is responsible for providing leadership to analytical chemistry laboratory operations and testing. This will include managing personnel and daily operations along with providing strategic direction to executive leadership regarding the enhancement and/or maintenance of operations (changing regulations, industry standards & best practices, training, equipment). The Director of Chemistry Quality Control will provide managerial, technical, operational and strategic leadership in the development and implementation of all quality control and related activities at a commercial GMP facility. This will include team leadership, Quality control business process build out, methods transfer, feasibility assessment, qualification/validation and execution of multiple methods. This role will require full collaboration with analytical development, manufacturing operations, Quality Assurance, and Regulatory.

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:

Leading and directing the Chemistry department, 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.
Establishing and enforcing effective SOPs and training documents to promote consistency and compliance within the team.
Oversees execution of testing including routine lot related analysis, and raw material testing. Generation and approval of certificates of analysis for product release.
Leads development, implementation, enhancement and maintenance of QC systems.
Evaluating QC systems and recommending and/or implementing system improvements and CAPEX projects.
Conducting laboratory investigations and writing reports for deviations, Environmental Monitoring excursions, and Out of Specification results.
Ensuring that development and implementation of testing programs meet departmental, company, and regulatory compliance requirements.
Taking ownership of multidepartment projects (identifying tasks, assigning responsibilities and timelines, and ensuring timely completion of projects).
Developing effective partnerships with other departments to facilitate problem solving and resolution of issues.
Coordinates with operations and supply management team for scheduling and test material availability to meet production demand and timely delivery of finished goods to distribution.
Provides Analytical documents for regulatory submission
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.

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:

Bachelor’s Degree, preferable in a scientific discipline. A Master’s Degree in chemistry is preferable.
Minimum of 5 years of Pharmaceutical Quality Experience.
Minimum of 2 years of people management experience.
Excellent written, verbal, and presentation skills, especially the ability to communicate effectively and work effectively in a multi-disciplinary team.
Previous experience working with FDA and participating in regulatory agency inspections.
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.

Work is performed in a typical office environment, laboratory and manufacturing areas, with standard office equipment available. Work is generally performed seated but may require standing and walking for up to 20% of the time. Safety PPE is required when entering manufacturing and laboratory areas.

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.