Director External Manufacturing

The Impact You Will Make:As the Director of External Manufacturing you are responsible for the strategy oversight and performance of all outsourced manufacturing activities for medical device this role you will ensure external manufacturers deliver safe effective compliant and costeffective devices that meet global regulatory requirements and company standards throughout the product as the primary executive interface with Contract Manufacturing Organizations (CMOs) and key suppliers you will ensure robust quality systems dependable supply and continuous improvements are met. Directly influencing product availability regulatory success cost structure and the longterm supplier you a proven leader with experience in medical device manufacturing ideally within a highly regulated environment This position will allow you to impact and shape a critical part of our operations working with cutting-edge medical technologies essential to ensuring patients receive safe highquality medical devices while enabling the business to scale efficiently. Key Responsibilities include but are not limited to:Define/execute the external manufacturing strategy in alignment with product portfolios regulatory pathways and growth makevsbuy decisions supplier segmentation and external network and onboard CMOs for finished devices subassemblies and critical as the senior escalation point for CMOs and strategic clear governance models including KPIs QBRs and executive steering performance accountability across quality delivery cost and external manufacturing activities comply with: ISO 13485/FDA 21 CFR Part 820 (QSR)/EU MDR / UKCA and other global regulatory audits inspections and notified body interactions managing supplier corrective actions (SCARs) deviations and field strong supplier controls including change management and risk consistent ontime infull (OTIF) supply risk management activities including dual sourcing and secondsite strategies business continuity and capacity continuous improvement initiatives across external design transfer and manufacturing process validation (IQ/OQ/PQ) at successful scaleup and launch readiness for new lifecycle activities including process optimization cost reduction and obsolescence external manufacturing budgets and cost manufacturing and quality agreements pricing capacity commitments and servicelevel yearoveryear cost improvements without compromising quality or supply closely with R&D Quality Supply Chain Regulatory and Commercial transparent reporting on performance risks and escalation topics to senior & Experience:10 years experience in medical device manufacturing operations or technical operations with outsourced manufacturing experience managing CMOs and critical working knowledge of global medical device regulatory and quality leadership and stakeholdermanagement skills at senior managing global CMO networks and complex product portfolios is to Class II and/or Class III medical devices is Competencies:External manufacturing and quality system management and and commercial building and management and continuous Capabilities:Inspire and motivate your team to achieve excellence and by example with integrity professionalism and scientific interpersonal skills both written & verbal communication skills especially in cross-functional/leadership to changing priorities timelines and regulatory expectations without compromising on strong analytical and decision-making data to guide actions and continuously improves a high standard of accuracy completeness and data integrity and encourage a right first-time we Offer:Attractive compensation pension scheme (up to 10% employer contribution).25 days holiday per year (plus bank holidays) plus service days after 5 Medical sick pay. Employee Assistance Program with 24/7 confidential helpline support for employee and immediate assurance of four times life cover working hours. Wellness recognition on-site and cashback at many to work referral Information: Working Hours: 37.5hrs per weekLocation: Charnwood Campus Loughborough All applicants must be eligible to work in the believe our people make the difference at Kindeva we look for skilled passionate and driven professionals to come and work with us to help us excel in manufacturing technologies and processes which bring lifesaving products to patients worldwide.#LI-DNI