Principal Quality Engineer, Combination Devices
|Contact Name:||Larry O’Leary|
Our client is a development stage Lifescience company with an outstanding track record of innovation in their specialist therapeutic sector. This Principal Quality Engineer role is a unique opportunity at a development-stage company, with field-leading advisors, and a highly experienced technical/operational team. This role reports to the Chief Technical Officer.
As a Senior leader for Quality, you will be a key contributor to preclinical and clinical research supporting our internal and external programs and leading the development and execution of the QMS to ensure the organisation is positioned for the next phase of Development and Commercialisation.
The successful candidate will be a key member of the Technical Operations team, operating in a stand-alone role with responsibility for all QA/QC, including the management of external consultants/contractors and development of company personnel.
Ideally, the candidate will be a Quality Leader and SME with proven expertise in the area of complex combination devices with biologics, working in a therapeutics company or specialist CDMO/CMO. Experienced in development and manufacture of medical devices would be an advantage.
Responsibilities for this role:
Support the development and qualification of appropriate analytical testing and documentation to ensure the integrity of data generated for device, machines, etc.
Develop and execute appropriate batch release procedures for device parts, subassemblies and finished goods, production machines and delivery solutions for GMP / commercial use.
Leads the investigation, resolution and CAPAs for manufacture/test issues/deviations at external manufacturers/test laboratories.
Lead development and execution of suitable audit program for internal and external activities.
Expand the data integrity assurance to development activities in a phase/scope appropriate manner.
Contribute to discussions and scientific strategy for company’s partner programmes and promote the highest standards of scientific excellence and customer service within the company.
Provide inputs in Quality and Analytics to Project Teams and work cross-functionally with other scientific colleagues including scientists in Process Development and Process Engineering.
Working closely with the Process Development, Project & Vendor Management, Regulatory and Business Development teams in support of company technology and development programs.
Operate in a team environment, assume leadership roles in cross functional teams. The successful candidate will function well with all members of our team. Must act as a coach to existing company teams.
Provide timely, accurate and concise summaries and project reviews to the Senior Leadership Team.
Proactively identify and address issues and liabilities that could impact the development of the scientific programmes.
Contribute to regulatory submission documents as required for DMF or CMC sections of IND’s etc.
Participate in discussions with internal development teams and/or regulatory agencies as required.
Required expertise includes:
Experience in the development and management of a Quality system.
Experience in audits as both an auditor and auditee.
Experience in preparing, participating for External due diligence.
Experience and expertise in developing Analytical methods.
Demonstrable record of scientific impact.
Strong leadership and management skills, of both individuals and teams.
Self-starter capable of identifying and acting on needs and opportunities for company.
Excellent Analytical problem-solving skills with critical and creative thinking skills.
Experience in the review and writing of regulatory submission documents is an advantage.
Ability to work collaboratively with colleagues in other Functions and on Project Teams and an ability to interact with key stakeholders including external clients and board members.
Required experience includes:
Degree and ideally PhD or equivalent in immunology, cell biology, molecular biology, or related field.
7- 10 year + experience in industry in relevant QA/QC/analytics roles.
Experience in the development and management of GMP Quality Systems.
Excellent written and verbal communications skills, and the ability to present and defend positions and approaches to critical elements of the internal/external scientific and GMP programmes.
Demonstrated history of leading projects with internal and external team members.
Polished, professional, and nuanced verbal communication and interpersonal skills. This individual will represent the company at all levels of stakeholder engagement, internal and external.
Experience leading cross functional teams in a highly matrixed organization.
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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