Supply Network Change & Business Development Specialist

Quality Specialist

Rates: Competitive

Job Description

These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production, Site Management and others.

Duties and Responsibilities

• 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 company sites according to the project plans.

• Identify and manage Quality and Compliance risks that arise from projects
• Escalate cGMP/Regulatory compliance issues following internal procedures

• Building relationships with cross functional team and stakeholders

• Ensure business continuity in a changing environment, supporting sites internal / external
• Encourage collaboration across company to ensure cross-functional input to key decisions and initiatives

• 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 improvements

• 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 Gap Analysis

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.