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Dechra · 3 weeks ago

Quality Assurance Operations Manager

Fort Worth, TX

Full-time

Hybrid

Mid, Senior Level

3+ years exp

Dechra Pharmaceuticals PLC is a global specialist in veterinary pharmaceuticals. They are seeking a Quality Assurance Operations Manager to oversee compliance of the company quality system, manage quality policies and drive continuous improvement within their manufacturing facility in Fort Worth, TX.

BiotechnologyPharmaceuticalVeterinary

Culture & Values

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

Qualification

GMP complianceQuality Management SystemsAuditing techniquesRegulatory inspectionsQuality Metrics managementProject managementInterpersonal skillsAttention to detailTime managementLeadership skillsOrganisational skills

Required

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

Previous experience of project management, time management and people management

Demonstrates a 'can do' approach

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