This groundbreaking new role will enable Oral Care to develop and bring new OTC drugs to the market using the newly built processes under FDA's Monograph Reform. The Chemistry, Manufacturing, and Controls Section (CMC) of a regulatory submission fully describes the composition, manufacture, and specifications of the drug product and drug substance, including physical and chemical characterization and stability. QA plays a key role in the development of CMC documents, supporting the generation of defensible documents which meet regulatory needs and provide appropriate flexibility. To be successful, strong coordinated interaction is required between QA-CMC, Regulatory, Product Development, and Product Supply.
In this role you will be responsible for:
- Assuming the role as Quality Assurance liaison to develop procedures and systems to enable FDA Monograph Reform to come to life at P&G Oral Care
- Serving as the QA resource on key projects that plan to utilize the Monograph Reform process for "NDA" submissions
- Supporting release of product to be placed in clinical trials
The successful candidate will own:
- Understanding regulatory strategy by GPS as it relates to CMC and provide QA leadership for strategy utilization
- Interacting with functional technical representatives to obtain required input for CMD development
- Conducting QA audit of all information/data relative to CMC to ensure accuracy, completeness and traceability
- Confirming with PD, PS, ad QA as appropriate, that CMC commitments are appropriate per process capability/feasibility and desired standard of product quality
- Ensure appropriate technical review of CMC documents and provide for issue resolution
- Ideal candidate would have experience with FDA New Drug Application (NDA) submissions. Experience in quality systems and regulated businesses for Drug, Cosmetics or Medical Device regulations – ISO and/or FDA (or other BOHs).
- Background in clinical studies, including GMP/GLP/GCP requirements.
- Bachelor's degree required
- Science background required (Chemistry, Engineering, Pharmacy, or similar)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS status or any other legally protected factor.
Immigration sponsorship is not available for this role. As a general matter, Procter & Gamble does not sponsor candidates for nonimmigrant visas or permanent residency. However, Procter & Gamble may make exceptions on a discretionary basis. Any exceptions would be based on the Company's specific business needs at the time and place of recruitment as well as the particular qualifications of the individual.
Procter & Gamble participates in e-verify as required by law.
Qualified individuals will not be disadvantaged based on being unemployed.
To apply for this job please visit topspotjobs.com.