Overview

Reference Number: JO-2001-443690
Senior Quality Supplier Manager
Rate: Negotiable
Job Type: Contract
Location: Macclesfield

Senior Quality Supplier Manager

Senior Quality Supplier Manager Contract, Pharma, Macclesfield

Duration: 6 months (possibly of extension)
Salary: Very competitive, please contact me directly for this
Location: Macclesfield

If you are looking for a change so you can work in a fun and friendly environment for a leading pharmaceutical organisation, why not apply for this role today?

Role

He / she will be responsible for the Quality management of assigned External Suppliers within the API & F & P PCO Supplier management teams and/or Category Team and subcategory Team (CT & sCT) [for Direct Material Supplier (DMS) PCO].

Main Responsibilities

– Planning for, supporting and participating in Regulatory Agency inspections of their Suppliers and company sites (regarding Quality management for supply of external materials to the Sites)
– As needed, perform Quality Audits within their technology area, as a Guest Auditor on the WWAG lead audit team
– Serve as Global Supplier Quality representative on Issue Management Teams
– Provide expert Quality input to NPI, Asset Strategy and/or Value Delivery projects. This includes identifying and assessing Suppliers, establishing Suppliers way of working with Global Supplier Quality and supporting the Supplier through to regulatory approval
– Liaise with Suppliers to ensure successful delivery of projects
– Make decisions and advise the Supplier Management Team regarding quality and pharmaceutical technology issues within their area of expertise
– Responsible for Quality Supplier Management including but not limited to: Annual Assessments; Quality Agreements; trending and reporting of data; assessing, reviewing and improving quality systems at Suppliers; attendance at Quality and Business Review Meetings
– Performs the Quality review and/or approval of the following cGMP documentation for their Suppliers including Change Requests, Product Quality Reviews (API and F&P PCOs only) or Supplier Quality Review (DMS)
– CMC documentation (ANGEL) associated with changes or product establishment at Suppliers (API and F&P PCOs only)
– Development and technology transfer documentation (API and F&P PCOs only), along with Director, Supply and Quality Systems, Global Supplier Quality
– Quality Investigations (Deviations, Product Quality Complaints)
– Responsible for quality issues escalation and resolution at the Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain
– Proactively ensures GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s)
– As a member of a Supplier Management team, responsible for supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s)
– Collaborates in data analysis and report creation on quality metrics and key performance indicators
– Participates in GSQ self-inspection program, auditing processes and procedures
– Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the PCO Supplier Management team

Skills/Requirements

– Bachelors degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering
– Must have API experience in QA environment, ideally needs to be in external manufacturing (internal will also be considered)
– Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
– Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment
– Understanding of industry standards such as Pharmacopeia, ISO standards, etc.
– Demonstrated experience working cross functionally and managing significant improvement initiatives (e.g. project management skills)
– Ability to work independently under his/her own initiative
– Ability to travel nationally and internationally as required approximately 25% of their time
– Experience working in a PCO/PET organization or Lean/Six Sigma training
– Multi-site / multi-functional experience
– Proven experience in Quality Assurance or combination of Quality and Technical

Not ready to apply or have some questions first? No problem, please feel free to contact me, Juber Rahman at any time on +44 (0) 207 822 1710 / juber.rahman@clinicalprofessionals.eu

If this role is not suited to your skillset, please feel free to share these details within your professional networks as we do offer a generous bonus referral scheme of 250 in vouchers should we go on to successfully please someone you recommend to us.

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