Senior Operations Manager

ZipRecruiter; Manchester; On-site; GBP 100,000 - 125,000; Full time

Job description

Job Description

Function:

The position is full-time, based at the Phagenesis UK Manchester office, reporting to the COO and interfacing with Production, Quality and Commercial business units. The Senior Operations Manager will be directly responsible for all outsourced manufacturing and supply chain activities in support of Phagenesis medical devices products. This will include scalability of manufacturing processes and capabilities in line with business needs. In addition, through line management of the Production unit lead, they will be responsible for production, shipping and logistics activities. Lastly, they will manage the facilities and infrastructure at the Manchester offices including acting as the UK contact for IT related matters.

Responsibilities:

1. Manage day-to-day operations and strategic relationships with contract manufacturers.
2. Ensure production plans align with demand forecasts, inventory targets, and regulatory requirements.
3. Develop and manage the production schedule in collaboration with supply chain and demand planning.
4. Identify and resolve potential supply risks and bottlenecks proactively.
5. Partner closely with Quality and Regulatory teams to ensure manufacturing processes and documentation meet ISO 13485, FDA, and other relevant standards.
6. Support investigations related to manufacturing issues.
7. Identify opportunities for cost reduction, lead time improvement, and process efficiency both internally and externally.
8. Support design for manufacturability (DFM) in collaboration with R&D and engineering.
9. Support scale-up activities as product demand increases, including tech transfers and process validation.
10. Lead or support cross-functional projects related to production readiness, new product introductions (NPI), and lifecycle management.

Essential Experience:

1. 7+ years of experience in medical device manufacturing or production management, preferably with outsourced contract manufacturing partners.
2. Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and related quality systems.
3. Track record in the manufacture of sterile disposable medical devices.
4. Proven ability to manage supplier performance and manufacturing relationships.
5. Experience with NPI, process validation (IQ/OQ/PQ), and change control.
6. Excellent project management and communication skills.
7. Track record of capacity building within manufacturing processes.

Desirable Experience:

1. Experience with Class II or III medical devices.
2. Familiarity with ERP systems (e.g., SAP, NetSuite).
3. Lean or Six Sigma certification a plus.
4. Strong analytical and problem-solving capabilities.
5. Manufacturing of electronic and software containing devices.

What We Offer:

1. Competitive salary range.
2. Benefits package.
3. Opportunities for professional growth and development.
4. Collaborative and innovative work environment.

Phagenesis is an equal opportunity employer, committed to fostering a diverse and inclusive work environment. We welcome applications from all qualified individuals, regardless of race, gender, belief, or background.

If you're passionate about transforming the lives of people with dysphagia through revolutionary treatments, we want to hear from you!

We look forward to receiving your application!