Position Details

Site Quality responsibility to provide technical expertise & leadership for Quality & compliance topics/issues.
Provide strategic guidance with management related to QA operations, approaches to deviation investigations & improvements to ensure robust performance.
Ensure schedules for review & approval of GMP documents are developed & maintained to meet the commercial supply timelines.
Provide sound support to operations, engineering, supply chain & material movement for commercial products.
Ensure relevant QA documents & procedures are approved to schedule to support technology transfers & NPIs.
Provide strategic leadership for deviation investigations, including root cause analysis & corrective & preventive action proposals & initiatives.
Lead QA review & approval of SOPs, batch process records, policies, validation protocols & reports.
Develop objectives for the QA department & direct reports, monitor performance & progress against departmental objectives & prepare performance reviews & development plans for direct reports.
Provide support & expertise for the preparation of regulatory submissions, inspection readiness activities during health authority inspections including leading audits with inspectors, responses to inspection observations & monitoring progress of follow up actions.
Support audits of GMP material suppliers & Providers executed according to PAHC Supplier Management/audit program. Provide support for improvement & follow up CAPAs.
Conduct work activities in compliance with Safety, Health and Welfare at Work legislation & Company policies.
Other duties as assigned.

COMPETENCIES

Have achieved a satisfactory level of technical & professional skill/knowledge in position related areas, keep up with current developments & trends.
Strong technical knowledge as it applies to QMS, QA & related regulatory requirements.
An understanding of EU GMP, ICH, HACCP (Feed Safety & Risk Assessment/Management) and compendia regulations & guidance for Veterinary Medicinal Products & Feed Additives.
Proven ability to manage complex quality issues, direct cost, effective quality programs & deliver against Quality metrics.
Identify & understand issues, problems & opportunities & compare data to draw conclusions & develop solutions consistent with the facts.
Ability to form strong relationships cross functionally.
Always be aware of conditions that affect employees & product safety.
Set high standards of performance; assume responsibility & accountability for successfully completing assignments/tasks.

EDUCATION/EXPERIENCE

Advance degree (Masters, PhD) in a technical discipline (e.g. biochemistry, chemistry, pharmacy) minimum of 7 years’ experience in a GMP Quality environment with a minimum of 3 years in a managerial role: or equivalent combination of education & experience is required.
QP eligibility & experience of releasing batches is required.
Minimum of 7 years’ relevant experience within a pharmaceutical (preferably Veterinary) industry/related field is desirable.
Minimum of 3 years’ experience as a named QP for manufacture of commercial medicines is desirable.
Demonstrated success records in leading regulatory audits is desirable.
In depth knowledge of current regulatory requirements for manufacturing technology in support of GMP operations supporting commercial manufacturing is desired.
Direct experience of GMP management within a pharma/biopharma company is essential & will include exposure to Health Authority inspections/audits & certifying 3rd party organizations desirable.
Demonstrated success in quality management & the resolution significant quality/technical challenges desirable.