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Job Title: External Supply Network Change & Business Development Quality Specialist
Dept: External Supply Network Change & Business DevelopmentLine Manager Job Title: Quality Manager / Director
Job Purpose:Reporting to the Business Development and Network Strategy Quality Manager or Director, this role supports the PSC Network Change and Business Development to ensure products and operations comply with client Quality expectations (QMS) and regulatory requirements. Depending on project scoping, the role will provide the support required for the oversight and management of the Quality plan relating to divestments or integration of assets.This role will need to establish effective working relationship with the key contacts of the assigned project teams, to ensure client's product quality and reputation is protected during engagement of external teams to support the implementation of new External Supplier or significant changes for the existing client network. These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production, Site Management and others.The role will support improvement, standardization and management of quality systems and processes.Key Responsibilities (10 bullet points maximum):Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the roleAccountable for ensuring teams deliver:• Management of project Quality workstream activities according to the project plans• Contribute to compliance and quality gap analysis• Deliver Quality Agreement plan between appropriate internal and external stakeholders and signatories• Negotiation of Quality Agreement Content to deliver plan• Monitor effective and timely registration through flow of information from sites and between project function• Manage quality activities for product transfers into External Suppliers from either current suppliers or client sites according to the project plans.Risk Management• Identify and manage Quality and Compliance risks that arise from projects• Escalate cGMP/Regulatory compliance issues following internal proceduresStrong Relationships Management• Building relationships with cross functional team and stakeholdersChange Management• Ensure business continuity in a changing environment, supporting sites internal / external• Encourage collaboration across client to ensure cross-functional input to key decisions and initiativesContinuous Improvement• Proactively drive a mindset of continuous improvement of processes, value creation and cost savings without compromising compliance, quality or customer service across the team• Support management of quality systems and process improvementsDescribe what experience this position will require the job holder to have obtained in past roles within or outside of client that would demonstrate a level of proficiency in the stated role.Minimum Level of Job-Related Experience required • Knowledge of quality systems principles and practical application• Knowledge and experience applying cGMP• Excellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasks.• Demonstrated ability to work and collaborate in a matrix organization, across multiple and geographic boundaries and work independently with minimal supervision• Technical knowledge of manufacturing, quality change and regulatory activities related to pharmaceutical products• Excellent verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective actions are put in place.• Good interpersonal, influencing and negotiation skills; with demonstrated ability to link to stakeholders around the business to ensure appropriate implementation and to persuade internal and external stakeholders to buy-into a specific course of action• Demonstrated project management skills• Risk Management• Knowledge of PSC network and supply• General competence in key Quality business areas:o Change controlo Quality Agreementso Gap Analysis
Why is this Level of Experience Required? Functional contributions for BD projectsC. Other Job-Related Skills/BackgroundList any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.• Demonstrated continuous improvement behaviours• Quality Management of External Supply Sites• Attention to Detail - Right First Time• Problem solving skills• Broad and thorough technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques/ processesDegree in life science or equivalent industry experience
