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Head of Manufacturing Quality Assurance
Il y a 4 mois
Description of Responsibilities:
The Head of Manufacturing Quality Assurance oversees the GMP Quality team and ensures adherence to quality standards and regulations throughout the manufacturing and clinical supply process.
Responsibilities:
- leadership, mentoring, training, and support to a team of GMP Quality professionals.
- with stakeholders to develop or revise manufacturing and clinical supply standards.
- training and compliance guidance on GMP standards to relevant team members.
- internal and external audits related to manufacturing and clinical supply activities.
- investigations and resolution of deviations related to manufacturing and clinical supply activities and vendors.
- readiness for inspections by facilitating meetings, reviewing documents, and conducting mock inspections.
- during inspections by managing requests and performing quality control reviews of documents.
- audit, inspection, deviation, and CAPA activities related to vendors to ensure timely closure and high quality.
- to Qualified Person certification activities by overseeing manufacturing intermediate batch release review.
- quality updates, maintain meeting minutes, and ensure completion of action items.
- and approve quality technical agreements with vendors to reflect necessary oversight throughout product development.
- and report on quality and compliance trends from audits, deviations, inspections, and CAPAs.
- critical findings and requests to the appropriate authority.
- opportunities for continuous improvement throughout the product lifecycle.
- other compliance activities as needed.
Requirements:
- Education, Training, and Certifications:
- or Doctorate degree in Pharmacy, Chemistry, Quality Management, or equivalent.
- in GMP, quality, and compliance.
- experience or certification as a GMP auditor and Qualified Person preferred.
- in English.
Professional Experience Level:
- 10 years of experience in pharmaceuticals, biotechnology, or related healthcare.
- 8 years of GMP-related Quality Assurance or relevant clinical trial experience.
Technical Skills:
- in project management and achieving results.
- to prioritize and manage multiple projects with demanding timelines.
- to detail and proficiency in analyzing complex data.
- in developing presentations and conducting trainings.
- of ICHQ6, ICHQ9, ICHQ10, and regulatory dossiers such as CTA/CTD.
- in outsourcing management (GMP-Chapter 7).
- Skills:
- experience in leading and managing diverse, inclusive, and equitable teams.
- team player focused on patient and company success.
- a continuous improvement mindset and positive attitude.
- communication skills, both verbal and written, with internal and external stakeholders.
