10 дней назад
Compliance Manager (Pharmaceutical Manufacturing)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Compliance Manager (Pharmaceutical Manufacturing): Leading GMP, quality, safety, and regulatory compliance for pharmaceutical packaging or manufacturing operations with an accent on inspection readiness, quality systems, risk management, and patient safety. Focus on investigating deviations, implementing CAPAs and change controls, managing audit readiness, and driving continuous improvement across the manufacturing site.
Location: Cramlington, Northumberland, United Kingdom; onsite at a pharmaceutical manufacturing site
Company
is a global healthcare company focused on women’s health, biosimilars, and a diverse portfolio of health solutions.
What you will do
- Act as the Integrated Process Team compliance lead and subject matter expert for GMP, regulatory compliance, quality systems, and patient safety.
- Provide compliance guidance, lead governance reviews, monitor quality metrics and risks, and report performance to site leadership.
- Support investigations, risk assessments, audits, CAPA implementation, and compliance with health, safety, and environmental requirements.
- Lead change controls and deviation investigations, including impact assessments, root cause analysis, and corrective and preventive actions.
- Maintain inspection readiness and coordinate responses to regulatory, customer, and internal audits.
- Drive quality culture, data integrity, Right First Time performance, continuous improvement, and team capability development.
Requirements
- Degree in science, pharmacy, engineering, quality, or a related discipline.
- Significant experience in pharmaceutical manufacturing or a regulated healthcare environment.
- Strong knowledge of GMP requirements and pharmaceutical quality systems.
- Experience managing deviations, investigations, CAPAs, and change controls.
- Leadership, stakeholder management, analytical, problem-solving, communication, planning, and organisational skills.
- Strong risk-based decision-making, attention to detail, and continuous improvement mindset.
Nice to have
- Lean Six Sigma or continuous improvement qualification.
- Experience with regulatory inspections and audit management.
Culture & Benefits
- Regular employment position with no relocation offered.
- Inclusive equal opportunity environment.
- Work focused on safe, reliable, and compliant pharmaceutical manufacturing.
- Employees must meet applicable travel, credentialing, and vaccination requirements.
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