Project Manager in Plymouth

Who are Advanced Medical Solutions? AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label.

Since 2019, the Group has made seven acquisitions: Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll and Peters Surgical. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in various countries. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees.

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

Job Details: To lead allocated project to success in compliance with the requirements of cGMP, FDA QSR 21CFR 820, ISO13485 & European Medical Devices Directive MDD94/42/EEC and Health, Safety and Environmental Legislation. Timeline, budget and cost control are priority. Working initially on key project - Project Buzzard (Additional projects to follow).

Assess current business needs and requirements against the business case. Provide scope for the industrialisation plan, review options within scope. Working with relevant stakeholders in a structured process for project delivery. Delivering "key" projects for the A&S operations team.

What will this role involve?

• Leadership of all aspects of the project: including outlining plan, project development meetings, budget and time management.
• Development of all aspect of the Operational delivery of the product (Buzzard).
• Consult and negotiate with engineering, equipment, service suppliers and contractors to ensure contracts, specifications and cost estimates provide the best value possible.
• To provide timely documentation, IQ/OQ/PQ protocols and reports, work instructions, risk assessments, certification as required to satisfy regulatory and legislative requirements.
• Assess the feasibility of investments in new buildings and alternatives such as leasing of properties and extensions to existing facilities.
• Manage contractors working on site and ensure compliance with company and legal HSE requirements.
• Enhancing organisational culture and performance through effective management of change initiatives.
• Carrying out all activities in compliance with cGMP, FDA QSR 21CFR820.
• Some international travel 20% (Israel).

What we're looking for?

• Prince 2 or APMP qualified project management.
• Excellent communication and stakeholder management via a structured Operating Rhythm approach.
• Substantial experience of working in Project Management on Major Industrialisation projects.
• Previous Leadership experience in a new production line development and or configuration role.
• Can demonstrate an excellent experience based knowledge of quality management systems.
• Can demonstrate substantial lean process understanding and implementation.
• Has worked in and is committed to the implementation of industrialization utilising Prince 2 methodology.
• Can deliver monthly report outs to key stakeholders.
• Can demonstrate prior achievement in the effective management of organisational change.