Site Quality Head

About This Role

The Site Quality Head will provide strong leadership and oversight for QA, QC, and Compliance activities, ensuring the supply of quality products and cGMP compliance at the site. This role is responsible for setting and executing quality goals in alignment with Global Quality Goals and assuring site readiness for regulatory and customer inspections.

Responsibilities

• Ensure all finished products are safe and effective as per cGMP requirements, regulatory commitments, and internal policies.
• Set site quality goals and strategic direction in alignment with global quality objectives and maintain the Site Quality Index Score.
• Track, trend, maintain, and report all Quality and business metrics to monitor and action all QA & QC compliance activities.
• Prevent Quality or regulatory non-compliance issues and address them through corrective and preventive actions (CAPA).
• Ensure rationalization and management of Quality processes, operations, and systems, performing gap analysis for continuous improvements.
• Manage resource planning, head count projections, site budget, and capital budget for organizational development.
• Drive continuous Quality & Compliance improvement initiatives, standardizations, and efficiency gains to enhance compliance and reduce costs.
• Coach and develop direct and indirect reports through performance feedback, annual reviews, and training opportunities.
• Ensure raw materials, packaging materials, and finished products are tested and released according to approved specifications and timelines.
• Ensure all DEA requirements for controlled substances are met at the site.

Requirements

• 15+ years pharmaceutical quality management experience
• 5+ years in a leadership role
• Significant experience in oral solid dosage
• Strong knowledge of domestic and international cGMPs
• Excellent and detailed knowledge of Quality/Compliance processes and programs for development and commercial products
• Working knowledge of safety and environment regulations and guidelines
• Strong comprehensive knowledge of USFDA 21 CFR regulations Part 11: EC/ER requirements, GMP requirements of various regulatory bodies (USFDA/ MHRA/ EU GMP/ PMDA)
• Strong comprehensive knowledge of ICH Guidelines, FDA and Health Canada Regulations
• Strong comprehensive knowledge of DEA regulations and requirements
• Proven ability to lead, manage, and motivate people with a variety of skill sets
• Strong organizational, interpersonal, and communication skills
• Excellent negotiation skills, relational skills and ability to communicate effectively with all levels of the organization and external stakeholders

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy or relevant engineering or life science field
• Minimum fifteen (15) years of experience in pharmaceutical quality management, and minimum five (5) years of experience in a leadership role.

Nice to Have

• Advanced Degree
• Ability to work effectively in an international matrixed organization

Skills

* Required skills

Benefits