Job Description
The Quality Assurance Manager role is responsible for all quality systems and the implementation of supportive processes for combination products (devices). The QA Manager will ensure internal processes and metrics are aligned to create a high level of product quality and consistency. They 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.
Key Responsibilities:
- Ensure the site 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 Organisations (CRO’s) from Auditors, Contract Auditors and Regulatory Agencies.
- Where problems arise, 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 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 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 combination products defects at any time.
- 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 biotech / pharmaceutical / bio pharmaceutical companies.
- Experience of medical device (Design History Files) and combination products a distinct advantage.
- 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 commercialisation.
- 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.
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