Senior Quality Operations Manager, Medtech start-up
|Contact Name:||Larry O’Leary|
Our client, a Medtech company based in Galway who a number of incredibly new innovative products coming through development, now seeks a suitably experienced Quality Operations Manager who will primarily establish the Quality function and exercise Stakeholder Management of associated functions to get this new site ready for commercial manufacture and product launch for FDA regulated environment.
This permanent role represents an attractive opportunity for career progression within site and global teams. The preferred candidate will have strong experience in New Product Development / New Product Introductions.
Note: this role is at Associate Director level plus package.
~ Quality function will include; building and hiring the Quality team, setting goals and objectives for the group, managing team and roll out of a performance development programme for each team member.
~ Stakeholder management and partnership with leadership group; Supplier/Vendors, Supply Chain, Manufacturing Operations, Engineering and Regulatory Affairs.
The successful candidate will be responsible for developing Quality Systems, Operational Processes and Procedures for Manufacturing Operations that will enable the site to deliver high Quality Product to EU, FDA and associated regulations.
Quality System oversight will include; Deviations, CAPA, Change Control, Audits readiness, Customer Complaints, Supplier Qualification including management of supplier and customer bona fides.
Manage and drive supplier qualification activities ensuring approved supplier and customer lists are maintained.
Significant Stakeholder Management is required across all functions, ensuring transition of new products from development to commercial manufacture meeting all applicable quality standards, regulations and customer requirements.
Lead preparation of quality function, processes and procedures in advance of regulatory inspections and customer audits.
Requirements for Quality Operations Manager:
Bachelors Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable.
Approximately 10 years’ experience in GMP, encompassing Quality Management or Compliance role.
Working knowledge of FDA regulations and all applicable regulations associated with European and ROW markets.
Proven ability to influence across function and at senior levels - building strong networks internally & externally.
Good technical capabilities, communication skills, teamwork abilities and initiative.
Proven ability to manage complex quality issues and deliver against quality strategies.
Please phone Larry on +353 (0) 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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