Job Description
The Associate Director Quality Operations and CMC will be responsible for performing key Quality tasks in respect of Company products and development/clinical projects. Work in the Quality Group, which oversees contract manufacturing and distribution operations, supply chain operations and development functions as well as internal Quality Systems.
The AD Quality Operations and CMC will report directly to the Senior Director Quality and CMC.
Responsibilities:
AD Of Quality Operations and CMC will be primarily responsible for ensuring regulatory compliance for all medicinal products distributed by QA/RP function and supporting through proactive monitoring, the quality performance of contract manufacturers, distributors and material suppliers to applicable GMP/GDP standards. This individual will receive assignments in the form of goals.
Responsible for:
Leading and monitoring the daily operations at Contract Manufacturer(s), responsible for oversight of batch review and disposition, reviewing and approving product complaints, deviations, change controls, and leading product related investigations.
Leading product related investigations and supporting product quality related priorities and tasks at the respective contract manufacturers, distributors and/or suppliers.
Designing, Implementing and improving quality systems to realize the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review and annual report completion on time.
Building authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Technical Quality Agreements (TQAs)
Leading external audits and assisting in internal audits and regulatory agency inspections as needed.
Ensure compliance of all respective contract manufacturers/suppliers to both internal company requirements and country specific regulations.
Highlight any risks associated with maintaining supply o the commercial drug products to all markets and offer innovative and effective ways to minimize such risks.
Collaborate with all contract manufacturers, packagers, and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of drug product to the markets.
Participate in due diligence activities associated with strategic partnerships or new company acquisitions, supporting technology transfer, process scale-up and process improvement protect as needed.
Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, packagers and laboratories, as required.
Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company specific GMP/GDP activities. In this respect, it may be necessary to collaborate with company Regulatory Affairs department and liaise with regulatory agencies in the process of resolving GMP/GDP specific quality issues.
Coordinate and prepare CMC (Quality) documentation for submissions and amendments/ variations (e.g., NDA/BLA submissions) inclusive of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards.
Prepare responses to health authority comments and questions as they related to Quality sections.
Evaluate proposed changes to the manufacturing and supply chain processes, including conducting regulatory impact assessments, and authorize these changes, if appropriate.
Support management of the supplier approval program and execute supplier audits as per the external audit schedule.
Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, as appropriate.
Communicate, where appropriate, with the Compliance group, on areas of common interest.
Communicate, where appropriate, with all Global personnel and contribute to the development of global systems and procedures, as required.
Contribute to the design and implementation of best practice quality improvement programs and company expansion programs.
Contribute to the development of quality policies and procedures and participate in the internal audit program, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
Contribute, as required, to the development of new drugs, which will deliver a robust product pipeline without significant delays in the regulatory approval process.
Professional Competencies:
A Masters or Ph.D. level in a science discipline is required, with an excellent understanding of quality assurance and CMC regulatory requirements.
Qualified/Responsible Person status is desirable.
A strong understanding of and experience in quality management is essential with a proven track record in people management and personal development.
At least 10 years' experience gained in finished product pharmaceutical manufacturing is required.
Knowledge of QA for all pharmaceutical dosage forms and drug substance manufacture is desirable. Knowledge of CTD format is desired. An excellent understanding of quality guidelines and regulatory requirements as they apply to the industry is required. Customer orientated with excellent communication skills and the ability to apply pragmatic logic to problem-solving and issue resolution is also required.
For further information on this Director Associate QA Operations and CMC 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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