Quality Supplier Manager

Job title : Quality Supplier Manager
Location : Cheshire East
Job type : Contract/Freelance
Salary : Negotiable
Contact name : Pauline Markina
Contact email : pauline.markina@secpharma.com

This position sits in the Global Supplier Quality (GSQ) organisation which leads Supplier Quality oversight for externally sourced materials to ensure that they align with the Quality Standard, are safe and effective and meet the required regulatory standards.

Client: Large Pharma
Duration: 6 months initially
Location: Cheshire (remote during pandemic)
IR35 Determination: Outside (open to LTD and umbrella)
Rate: Negotiable based on experience

Description:
This is a diverse and interesting role working with Suppliers, Contractors and a broad range of sites and functions. You will collaborate with colleagues and customers across many countries and interact cross-functionally with supply chain, supplier relationship, technical and project roles. Some travel may be required along with a high level of independence for the role.

Responsibilities:
- Provide Quality oversight globally for approximately 1,600 supplier sites. The scope of the organisation includes outsourced API, Biologics CMOs, Direct Materials including Devices, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.
- Responsible for assuring the quality of materials received by the client from the designated supplier portfolio and proactively ensure GMP and regulatory compliance during supplier related projects
- Responsible for the Quality System oversight of Supplier related product quality complaints, change controls, deviation investigations, issue management and escalation, and Quality Agreements between the client and External Suppliers; and the preparation and submission of Supplier Quality Risk Assessments, and support to Regulatory Agency inspections of supplier sites and site transfers
- Drive quality improvements at the supplier as part of a cross functional team
- Quality review and approval of Chemistry and Manufacturing Control (CMC) documents associated with changes or product establishment at suppliers.
- Maintaining a high level of understanding of relevant production processes and quality systems.

Requirements:
- Experience with outsourcing supplier management OR strong experience in QC/QA
- Degree in a science / technical field such as Pharmacy, Biology, Chemistry, Engineering or equivalent experience
- Broad experience with a minimum of 5 years relevant work experience in either the pharmaceutical operations environment or a pharmaceutical Quality Assurance role
- Excellent oral and written communication skills
- Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also, strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
- Demonstrated experience working cross-functionally and leading significant improvement initiatives (e.g. project management skills)
- Strong problem-solving skills
- Strong negotiating/influencing skills
- Ability to work independently under your own initiative.
- Ability to travel nationally and internationally as required up to approximately 10% of their time.

Desired skills:
- Experience working in a PCO/PET organisation or Lean/Six Sigma training.
- Multi-site / multi-functional experience - particularly within a manufacturing site environment.
- Proven experience in Quality Assurance or combination of Quality and Technical.