Quality Assurance Operations Manager

Dechra•Everman, TX

3d•Onsite

About The Position

We are look for a Quality Assurance Operational Manager for Dechra Pharmaceuticals Manufacturing at our Fort Worth, TX facility to promote, develop and oversee compliance of the company quality system. Effectively assuring compliance of customer requirements by managing quality policies, standards, procedures, programs and practices while driving and facilitating continuous improvement . This role has a broad and varied scope, and the successful candidate will have responsibility for duties including:

Requirements

Minimum of 3 years of experience in pharmaceutical industry with management experience
Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience of auditing/inspection techniques, including internal process/system and documentation audits, as well as experience of related quality assurance principles applicable to pharmaceutical manufacturing
Competency in management and tracking of Quality Metrics- CCs, CAPAs, Deviations, Complaints, PQRs, audits and audit reports
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
Demonstrates time management skills
Using logic and reasoning to identify solutions to problems
Ability to lead, motivate, coach, and teach others
First class organisational skills
Ability to prioritise, demonstrating good time management skills
Self-motivated, with the ability to work proactively using own initiative

Nice To Haves

Previous people leadership experience preferred
Previous experience working with MHRA, FDA and participating in regulatory agency inspections
Previous experience of project management, time management and people management Skills

Responsibilities

To oversee quality and ensure a strong factory floor presence within the Manufacturing and Packaging areas
To manage the CAPAs, Deviations, Audits and Vendor Quality Management Programs
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 Management Systems
To participate in internal and external audits, and support vendor quality management activities
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 (MHRA, FDA, EMA, etc.)
To assist the QA 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 conduct audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks as well as review/evaluate adequate completion of all planned actions 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
To author, review and/or authorise Standard Operating Procedures (SOPs)
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

Benefits

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 an other incentives for long-term financial wellness.
Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work

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