Job Description
This is an extraordinary 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 are in compliance with US, Canadian and EU regulations at all times and
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 Organization(s) (CMO’s)
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 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 jeopardize 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 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
The ideal candidate will have:
- 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 / bio pharmaceutical companies.
- Minimum of three years prior management experience.
- Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations.
- Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
- Experience in implementation and administration of quality systems for drug Development, manufacturing and quality control operations.
- Has a thorough understanding of risk management principles and methodologies and their application in Quality Management Systems for Drug Product Combination (devices).
- Skilled in writing regulatory submissions a distinct advantage.
- Strong written and oral communication skills.
- Has a thorough understanding of the regulatory process from IND through commercialization.
- Certified Lead Auditor.
- Ability to evolve as project needs change.
- Strong project management skills.
- Exceptional interpersonal skills with the ability to negotiate and resolve conflict with poise, tact and diplomacy.
- Ability to effectively integrate the quality functions into the business.
- Excellent verbal & written communication skills.
Travel: Approximately 10 to 20%
Cv to gerry@rftgroup.ie