Manager I - Supplier QualityApply Now Email Me Job ID SR0032031 Date posted 01/24/2019 Location:Neuchâtel, Switzerland
Responsible for the execution of Shire Tech Ops supplier management program. Along with Manager and Team, supports activities to fulfill all of the requirements for an effective and sustainable TechOps supplier management program. Responsible for results in terms of product quality and conformance to regulations and Shire quality policies.
As part of the global Supplier Quality team, the Job Holder is responsible for ensuring material and service suppliers meet Shire qualification requirements. The Job Holder will perform on-site audits at suppliers and as applicable internal manufacturing sites and will be involved in negotiation of Quality Agreements. Additionally, the Job Holder will be the primary point of contact for local sites in Ireland and UK region for SQ topics and will support other regions and Operational Units and Functional Teams as applicable.
Drive Supplier qualification and maintenance activities
Lead /participate in supplier audits (focus on high risk suppliers). Evaluate supplier audit responses for adequacy, including root cause analysis, appropriateness of corrective actions and timeliness. Communicate results of audits in presentations and written reports. Resolve issues and escalate risks and critical concerns, as appropriate.
Develop, negotiate and maintain Quality Agreements with the suppliers as part of the initial qualification as well as routine maintenance.
Supplier Performance and Relationship Management
Lead and support responsible parties with supplier complaint management (SCARs), supplier change management (SNCs)
Actively support collection and analysis of key performance indicators and supplier performance review data (Monitoring and Metrics); drive/ support supplier risk management and lead/participate in supplier development and improvement projects
Lead and support the continuous improvement of the Supplier Quality program, processes and procedures; serve as SQ project owner; identify risks and opportunities for improvements as well as actions derived from the risk analyses; lead/participate in SQ related process improvement projects
Serve as a subject matter expert for Supplier Quality and represent Supplier Quality in cross-functional teams and Management Reviews
Provide researched and fact-supported information and opinions. Educate stakeholders on SQ processes, regulations, quality systems and technical issues.
Participate in external inspection preparation activities and provide support during external inspections.
Interface with regulators during inspections: act as Subject Matter Expert during inspections and audits to represent Supplier Quality
Skills and Experience :
- Minimum of a Bachelor’s Degree in a biological science, microbiology, chemistry, biochemistry or equivalent.
- Minimum of eight years’ experience in a quality assurance function in a pharmaceutical or biotechnology environment including at least two years’ experience in auditing techniques and interpreting regulations and quality systems, preferably as a quality/regulatory compliance auditor.
- Knowledge and competency in the use of Microsoft Office programs, including Word, PowerPoint and Excel. Database and SharePoint experience a plus.
- Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections highly desirable/preferred.
- Project management experience; Knowledge of /and experience with Project
- Management tools and processes desirable
- Supervisory experience is desirable.
- Certification by ASQ as a CQA is desirable.
- Lead Auditor training or ISO Lead Assessor Training is desirable.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.