Kindeva Drug Delivery
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 products.
In this role you will ensure external manufacturers deliver safe, effective, compliant, and cost effective devices that meet global regulatory requirements and company standards throughout the product lifecycle.
Serving 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 long term supplier capability.
Are 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, high quality 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 objectives.
- Lead make vs buy decisions, supplier segmentation, and external network design.
- Identify/assess/qualify, and onboard CMOs for finished devices, sub assemblies, and critical components.
- Act as the senior escalation point for CMOs and strategic suppliers.
- Establish clear governance models, including KPIs, QBRs, and executive steering forums.
- Drive performance accountability across quality, delivery, cost, and compliance.
- Ensure external manufacturing activities comply with: ISO 13485/FDA 21 CFR Part 820 (QSR)/EU MDR / UKCA and other global regulatory requirements.
- Support audits, inspections, and notified body interactions, managing supplier corrective actions (SCARs), deviations, and field actions.
- Maintain strong supplier controls, including change management and risk assessments.
- Ensure consistent on time, in full (OTIF) supply performance.
- Lead risk management activities including dual sourcing and second site strategies, business continuity and capacity planning.
- Drive continuous improvement initiatives across external operations.
- Oversee design transfer and manufacturing process validation (IQ/OQ/PQ) at CMOs.
- Ensure successful scale up and launch readiness for new products.
- Support lifecycle activities, including process optimization, cost reduction, and obsolescence management.
- Own external manufacturing budgets and cost performance.
- Negotiate manufacturing and quality agreements, pricing, capacity commitments, and service level expectations.
- Drive year over year cost improvements without compromising quality or supply resilience.
- Partner closely with R&D, Quality, Supply Chain, Regulatory, and Commercial teams.
- Provide transparent reporting on performance, risks, and escalation topics to senior leadership.
Skills & Experience:
- 10+ years’ experience in medical device manufacturing, operations, or technical operations, with outsourced manufacturing exposure.
- Proven experience managing CMOs and critical suppliers.
- Strong working knowledge of global medical device regulatory and quality systems.
- Demonstrated leadership and stakeholder management skills at senior levels.
- Experience managing global CMO networks and complex product portfolios is preferred.
- Exposure to Class II and/or Class III medical devices is desirable.
Core Competencies:
- External manufacturing leadership.
- Regulatory and quality system expertise.
- Risk management and decision making.
- Financial and commercial acumen.
- Relationship building and influence.
- Change management and continuous improvement.
Key Capabilities:
- Inspire and motivate your team to achieve excellence and accountability.
- Lead by example with integrity, professionalism, and scientific accuracy.
- Excellent interpersonal skills, both written & oral.
- Strong verbal communication skills, especially in cross-functional/leadership meetings.
- Adapt to changing priorities, timelines, and regulatory expectations without compromising on quality.
- Demonstrate strong analytical and decision-making skills.
- Use data to guide actions and continuously improves processes.
- Maintain a high standard of accuracy, completeness, and documentation.
- Champion data integrity and encourage a right first-time culture.
What we Offer:
- Attractive compensation package.
- Company pension scheme (up to 10% employer contribution).
- 25 days holiday per year (plus bank holidays) plus service days after 5 years.
- Private Medical Insurance.
- Company sick pay.
- Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family.
- Life assurance of four times life cover salary.
- Flexible working hours.
- Wellness programmes.
- Employee recognition program.
- Employee development.
- Free on-site parking.
- Discount and cashback at many retailers.
- Cycle to work scheme.
- Flu vaccinations.
- Employee referral scheme.
Additional Information:
Working Hours: 37.5hrs per week
Location: Charnwood Campus, Loughborough
All applicants must be eligible to work in the UK.
We 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.
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Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Kindeva is an Equal Opportunity Employer
