Quality Manager

PHIBRO ANIMAL HEALTH CORP; Medolla; In loco; EUR 90.000 - 110.000; Tempo pieno

Descrizione del lavoro

Phibro Animal Health Corporation in Medolla, Italy is seeking a Quality Manager to lead the QA team and drive GMP compliance across the site.

You will manage deviation investigations, approvals of SOPs and batch records, and support regulatory submissions and inspections. The role requires an advanced degree and extensive GMP QA experience, including QP eligibility.

Competenze

• Advanced degree in a technical discipline with 7 years in GMP Quality and 3 years in management.
• QP eligibility and experience releasing batches.
• 7+ years experience in pharmaceutical industry (vet preferred).
• 3+ years as named QP for manufacture of commercial medicines.
• Experience leading regulatory audits.

Mansioni

• Provide QA leadership for Quality and compliance topics.
• Guide QA operations, deviation investigations and improvements.
• Manage GMP document review and schedule maintenance.
• Support operations, engineering, supply chain, and material movement.
• Lead SOPs, batch records, validation protocols and reports review.
• Prepare regulatory submissions readiness and audits.
• Audit supplier controls and CAPA follow-up.
• Ensure safety compliance and company policies.

Conoscenze

QMS knowledge

QA & regulatory knowledge

EU GMP & ICH familiarity

Audits management

Root cause analysis

Cross-functional collaboration

Safety awareness

Formazione

Advanced degree in biochemistry/chemistry/pharmacy

QP eligibility

7+ years GMP Quality experience

3+ years as named QP

Experience with veterinary/pharma audits

Descrizione del lavoro

About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets.In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.

TheQuality Manageris an integral part of our Qualityteam based out of our Medolla, Italysite.

• 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.

Phibro is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

Business Unit:Animal Health & Mineral Nutrition
Division:Animal Health & Nutrition
Department:Quality
Location:Medolla, Italy
Work Schedule:Monday - Friday (40 Hours)