Site Quality Head

Recruiter
SANOFI
Location
Hertfordshire
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Overview

To provide strategic direction to, and manage the Haverhill Quality department to ensure it operates efficiently, in compliance with Sanofi and regulatory requirements, and in alignment with the site and company objectives and strategy.

Responsibilities

As part of the Haverhill Leadership Team, develop and manage business strategies designed to place the business in a highly competitive position, including development and maintenance of strategy for the Quality function in alignment with this strategy.

- Lead the Quality department, consisting of Quality Systems, Qualification & Validation, Regulatory and CMO Quality Management, Quality Assurance and Quality Control, provide direction, coaching and advice to the Quality staff to deliver consistent high performance
- Effectively network and be highly influential in order to persuade others to see Haverhill and the company in a positive way
- Work as an integral part of Sanofi's Quality organisation, including being aligned with and taking a leadership role in appropriate Quality initiatives
- Prepare and manage annual budgets and capital plans for the Quality department, and is responsible for budgetary control, ensuring that any deviations from approved Capital Plan are addressed and that quality risks are addressed as part of this plan
- Ensure that the Quality department is sufficiently resourced to enable team members to meet company and regulatory requirements, in particular in the following areas
- Final decision on acceptance for use or rejection of GMP materials including raw materials, excipients, packaging material and intermediates
- Verification of the compliance of the site with Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs)
- Verification of compliance of products with registration dossier requirements
- Verification that program and systems are implemented to consistently identify, analyse, evaluate, control and review potential or identified risks related to quality and compliance.
- Review and approval of changes that could potentially impact the quality of the product
- Maintenance and management of testing facilities to assure that materials and products meet their specifications, including approval of testing methods
- Verification of the proper management and monitoring of stability programs and necessary scientific studies for active pharmaceutical ingredients and marketed products
- Approval of subcontractors and suppliers involved in GxP activities, and maintenance of their approved status, including quality assessments, audits and approval of quality agreements
- Verification that the quality training and personnel qualification programs are managed according to Sanofi and regulatory requirements
- Verification that effective systems are used for the maintenance and calibration of critical equipment and instrumentation
- Verification that facilities, utilities, equipment, manufacturing processes, cleaning processes, analytical methods, computerised systems, and transport processes are qualified or validated when needed
- Conduct of self-inspections of site facilities, operations, procedures and systems to ensure conformance with GMPs, GDPs and related regulatory requirements
- Preparation, organisation and monitoring of regulatory inspections
- Working with site operations to identify root causes to identified problems and opportunities for quality system improvements
- Reporting to the appropriate level of management of instances of noncompliance to specifications, GMPs, GDPs, and regulatory requirements
- Monitoring progress on quality-related corrective and preventive actions to assure timely compliance and improvement
Investigation on deviations, failures, out of specifications and out of trends, product complaints and coordination of product recalls
- Control of returned non-defective products before reintroduction and distribution into the market
- Management of quality documentation, including review and approval of documentation with a GxP impact
- Approval of technology transfer and monographs as required at the particular development phase of the product

Requirements & Qualifications

Professional qualification in Chemistry, Microbiology, Pharmacy, Engineering or equivalent. Qualified QP is highly desirable

Substantial experience of successfully working at a senior level and be able to demonstrate a broad and deep technical and managerial understanding
Successful management experience and an advanced grasp of management techniques
Role model for Quality

Location Information

A commutable distance to Haverhill - within East Anglia

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients' needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.