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Quality Assurance Manager Combination Products

Contract Type: Permanent
Location: Dublin
Contact Name: Laurentina Kennedy
Contact Email: laurentina@rftgroup.ie

Job Description

Quality Assurance Manager, Combination Products
This is an extraordinarily exciting opportunity for a technically strong, bright, ambitious Quality Assurance expert with combination product experience. Our client is a young, fast-growing Device Quality Unity, at a Dublin based pharma company. With a management team who possesses a long history of outstanding business success, this highly entrepreneurial organisation is experiencing rapid growth and expansion across its global markets.

Job Spec

Reporting directly to the Quality Assurance Director, Device Quality Unity, this position will be responsible for the management of Quality and Compliance functions for combination product(s) (devices) at the Device Business Unit, based in Dublin.

Key responsibilities include
1) Providing functional oversight and quality support to in-house and CMO teams to ensure consistent implementation of quality concepts across all commercial and developmental programs
2) Monitor changes in national and international regulatory requirements in order to contribute effectively to strategic inputs and regulatory intelligence
3) Ensuring that all activities follow US, Canadian and EU regulations always
4) Liaising closely with our many contractors and material providers.

The newly appointed Device, Quality Assurance Manager will be responsible for supporting Device product design and development, product approval, sustainable manufacturing and supply principally through third-party development and manufacturing partners. The role exercises a comprehensive and contemporary understanding of conventional pharmaceutical manufacturing regulations as well as drug device regulations and approval strategies inclusive of ISO/GxP for medical devices.

The role is responsible for all quality systems and the implementation of supportive processes for combination products (devices). He / She will ensure that internal processes and metrics are aligned to create a high level of product quality and consistency. He / She will support quality systems having a continuous improvement mindset to achieve business objectives. This role is responsible for supporting the Quality function in an integrated way that supports the delivery of business unit goals.

Quality responsibilities within the scope of this job include the following:
Ensure that site(s) responsible for product manufacturing operates in a manner which is fully compliant with applicable cGMP’s and international standards resulting in minimal audit findings for our Contract Manufacturing Organisation(s) (CMO’s)
The role is responsible for all quality systems and the implementation of supportive processes for combination products (devices). You will ensure that internal processes and metrics are aligned to create a high level of product quality and consistency. You will support quality systems having a continuous improvement mindset to achieve business objectives. This role is responsible for supporting the Quality function in an integrated way that supports the delivery of business unit goals.

Quality responsibilities within the scope of this job include the following:
  • Ensure that site(s) responsible for product manufacturing operates in a manner which is fully compliant with applicable cGMP’s and international standards resulting in minimal audit findings for our Contract Manufacturing Organization(s) (CMO’s) and Contract Research Organizations (CRO’s) from Auditors, Contract Auditors and Regulatory Agencies.
  • Where problems arise, can exercise judgment within broadly defined parameters and policies to identify an appropriate course of action for obtaining results. Erroneous decisions will result in critical delay(s) in schedules and/or may jeopardise specific business activities
  • Promote quality awareness and continuous improvement at the site and across the supplier and CMO network ensuring the proper interface of the site(s) quality function for commercial and development product(s) as required.
  • Review of partnerships/relationships with service provider companies and where appropriate, manage the relationship through a formal Technical Agreement.
  • Supervision of and timely close-out of product/process investigations, complaints, deviations and any other paperwork associated with release of the finished product or clinical material.
  • Maintenance of Quality Assurance Systems, in compliance with appropriate regulatory requirements (e.g. ISO, FDA, and EU).
  • Build strong relationships with internal and external customers to promote, enhance, and ensure quality awareness.
  • Support the corporate audit team to carry out internal/external audits
  • Provide QA technical input & assistance in Validation / Qualification activities that the company has oversight of, while making sure that all issues and trends are critically evaluated.
  • Review and approve batch release documentation.
  • Ensure timely preparation of and/or management of APQR’s.
  • Manage the company local Vendor Management Program and Change Control system.
  • Ensure all training assigned is carried out per due dates.
  • Implement and maintain Quality standards for product lifecycle management.
  • Maintain good application of compliance standards to enable excellent relationships with Regulatory agencies.
  • Develop and monitor appropriate metrics to track quality and process improvement.
  • Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals.
  • Responsible for identifying defects and the reporting of such device defects at any time.

Person Spec

BS degree in Engineering, Science, or Operations Management; Advanced Degree (s) preferred.
Position requires a Quality Assurance professional with a minimum of 8 years of experience in device and pharmaceutical/biopharmaceutical companies.
Minimum of three years prior management experience.
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For further information on this QA Manager Combination Products position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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