Director of Quality and Regulatory Affairs cmc Dublin
Our client is a highly ambitious young US pharmaceutical company but with an impressive track record of building highly successful global businesses. Its strategy is to acquire marketed products and late stage development projects to expand portfolio. It seeks to selectively in-license or acquire FDA approved and late-stage development pharmaceutical products in focused therapeutic areas
The Company’s management team has extensive experience in completing pharmaceutical transactions in a timely and collaborative manner, to the benefit of both parties. It has experience in a range of transaction structures including in-licensing and acquisition transactions, distribution, royalty and co-promotion agreements, and research and development collaborations.
Ambitious expansion plans have led to the establishment if this exciting newly created management position. This opportunity offers a rare chance to make a key contribution towards building a successful ambitious young company. The post holder will gain a wealth of experience across a wide spectrum of the industry including full spectrum of dosage forms, as well as Clinical, Regulatory CMC, and Manufacturing.
Job Spec :
The newly appointed Director of Quality and Regulatory Affairs cmc will be responsible for overview of quality and regulatory aspects of Company products and development projects. You will work in the Technical Operations team, which oversees contract manufacturing operations, selection of supply chain operations and development functions.
As, this position is responsible for the quality oversight of contractors to all applicable standards for the manufacture and disposition of drug products.
The individual may be responsible for, but is not limited to:
- Ensure quality systems are in place, as expected by appropriate agencies such as HPRA and FDA
- Monitoring the quality and manufacturing operations at contractors
- Performing batch disposition, reviewing and approving: batch records, specifications, deviations and change controls.
- Ensuring quality by design for development programs
- Designing and implementing quality metrics
- Facilitating technology transfer, process scale-up, and process improvement projects.
- Review or author quality and CMC documents e.g. annual product review, annual reports, stability reports, supplements
- Review general submissions
- Audit or coordinate auditing of clinical studies
- Member of the Company’s Compliance Committee
Person Spec :
- Bachelor’s degree in chemistry, biology or a related discipline
- Significant experience working in pharmaceutical industry. Experience should be in the quality assurance, quality control, development, and/or manufacturing areas.
- Thorough understanding of quality systems and cGMPs.
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
- Experience working in a fast paced high growth virtual environment offers a distinct advantage .
- Expertise in managing Wholesale Dealer’s Licence or GMP licence or IMP licence.
- Capable of hiring, managing and developing a high performing Quality and Regulatory team
- A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity
- There is a significant travel requirement (US and EU) with this role.
- Experience working with contract manufacturing
- Experience interfacing with regulatory bodies or working on regulatory submissions
- Highly organised, with exceptional time management and prioritisation
- Critical thinking/ evaluation of process problems
- Strong work ethic
CV to Gerry Kennedy The RFT Group firstname.lastname@example.org 01 2302400