Oncology Quality Assurance Manager Job at Discovery Solutions, Inc – Bridgewater, New Jersey
Position: Manager
Employer: Discovery Solutions, Inc.
Location: Bridgewater, NJ, United States of America (USA)
COMPANY
Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.
Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.
DESCRIPTION
The Oncology Quality Assurance Manager is responsible for supporting the management of oncology portfolio day to day activities from the Quality Assurance perspective. The incumbent works closely with the project/product teams and provides GCP consultation and support to the teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Provides day to day GCP support to assigned project teams, with support from the Portfolio lead as necessary.
* Contributes to QA risk based strategy and implementation to support goals of the portfolio or project team.
* Supports the development of Risk Based Quality Assurance strategy and risk assessment tool.
* Obtains feedback and buy-ins from QA leadership and various stakeholders on the above, including clinical operations, regulatory affairs, medical affairs, and project management.
* Actively implements Risk Based Quality Assurance strategy and ensure timely completion of risk assessment on study protocols and associated vendors.
* Works closely with the Clinical Auditing group, clinical and project teams.
* Monitors portfolio activities from QA perspectives. Proactively identifies risks and provides guidance on risk mitigation.
* Acquires current knowledge on significant development on the compound level from clinical and regulatory perspectives.
* Provides GCP consultation/support and present consistent and accurate advice to the portfolio.
* Supports the development and enhancement of QA procedures, guidance documents and tools covering oncology portfolio quality assessments.
* Conducts or participates in quality assessments to evaluate the processes and procedures.
* Perform data integrity and document reviews.
* Actively acquires practical knowledge of current and emerging global guidelines and regulations, relevant regulatory approaches and actions, and status of competitor/similar products to effectively develop and advance QA strategies.
* Support preparation, execution and close out of health authority inspections, as needed.
* Rapidly communicates significant development and issues within the portfolio to the Portfolio Lead.
* Support various quality initiatives in collaboration with other groups/departments as appropriate.
* Travels to other QA location, as required.
EXPERIENCE
* 3-5 years experience in clinical QA or other clinical quality management/QC role in biomedical science, clinical development, and regulatory compliance.
* Previous experience working in projects related to oncology and/or biotherapeutic or portfolio teams highly preferred.
* Demonstrated knowledge of ICH GCP, PV, clinical development and principles of quality assurance.
* Demonstrated knowledge of / experience within oncology therapeutic area e.g. Imaging, RECIST criteria.
* Analytical mindset to develop effective business and competitive strategies for dealing with current and future industry trends.
* Global perspective within the context of business needs and impact.
* Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format.
* Considers customers, including regulatory agencies, clinical and safety, in developing strategies, risk priorities and future direction.
* Builds wide network of alliance with key customers/stakeholders/colleagues and utilizes their input to drive strategic thinking and find collaborative partnerships.
* Manages and resolves conflicting priorities and delivers on commitments.
EDUCATION
Bachelor’s degree is required. Advanced degree desirable. Equivalent relevant professional experience may be considered.
Simply send your CV to jobs@researchgate.net and please mention this requisition number DMS 416829 in the subject line of your mail.