Our client is a recognized leader in the development of topical and transdermal products. Helping pharmaceutical and consumer companies develop safe, effective dermatological products has earned them a big reputation, despite being a smaller, close-knit organization. Recently they were acknowledged as one of the Top 10 Emerging Pharma Outsourcing Companies for 2021. This recognition is the latest in a series of recent accolades for the company. If you are an experienced QA professional and like smaller companies where you have a bigger role and impact, but don’t like risk, this could be the right company for you as they are a successful subsidiary of a larger international pharmaceutical company.
Key aspects to this role internally include direct monitoring and oversight of GLP/GMP lab activities, drafting SOPs, and ability to orchestrate and manage site audits. Externally, you will serve as the company’s Quality Assurance representative communicating quality function and methods to clients & collaborators. This role reports directly to the CEO.
Other responsibilities include:
- Implementing, training, maintaining & doing periodic review of SOPs in R&D and GLP environments & other quality documentation for GLP studies.
- Overseeing and supporting quality and compliance activities over study durations.
- Supporting deviation close out, reviewing investigation reports and initiating/following up on corrective and preventative actions.
- Performing and managing routine inspections of laboratories, ensuring compliance.
- Hosting quality audit visits by regulatory authorities and clients.
- Performing vendor site audits & review vendor quality documents.
For consideration, you must have:
- BSc, MSc (or PhD) in analytical chemistry, biochemistry, pharmaceutical science or related discipline with at least 4 years of relevant life sciences industry experience
- 3-8 years of experience in quality function for GLP or GMP environment in the life sciences industry
- Excellent organization, attention to detail, and analysis skills.
- Demonstrated excellence in working with groups with diverse backgrounds and communicating effectively in a collaborative small team environment.
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Experience with chromatographic quantitation techniques including HPLC, LC-MS, LC-MS/MS
- Direct experience of interaction(s) with FDA (including orchestrating and managing site audits)
- Ability to thrive in small company environment, outstanding personal skills to facilitate interactions with management, research staff at all levels, external stakeholders and clients, regulatory agency representatives, excellent organization, attention to detail, and analysis skills; excellent written and spoken communication strengths.
- Located in greater San Diego area
To apply for this position, confidentially email us here.