Alios BioPharma, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of QA and Compliance to be located in South San Francisco, CA.
Johnson & Johnson research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals.
The primary responsibility for this position will be establishing and managing the Alios Biopharma Quality and GMP compliance activities.
Responsibilities of the Director will include, but are not limited to:
• Providing leadership to and managing the GMP Quality Assurance function.
• Demonstrating leadership by ensuring the continual improvement of the Alios Quality Systems.
• Working with Janssen and other partners on all quality issues for joint projects.
• Overseeing and providing quality leadership the quality management of all CRO’s and CMO’s used to support all GMP functions.
• Establishing and overseeing the Quality Document Control system.
• Ensuring management of changes associated with products and processes are carried out appropriately using science and risk-based assessment to determine the impact of change.
• Providing leadership to and managing the Internal and External Audit programs.
• Identifying compliance risks and developing sound rationale as basis for the observations.
• Coordinating activities and supporting interactions during regulatory agency inspections and partner audits.
• Monitoring, communicating and acting on any emerging trends that may potentially impact on product quality.
• Analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
• Be a Subject matter Expert (SME) for interpreting regulations and applying them to compliance situations as applicable for Phase 1 to 3 drug development programs.
• The ideal candidate will have an outlook that is uncompromisingly committed to quality.
• The ideal candidate must be a motivated self-starter; detail- and results-oriented
• The ideal candidate will be well organized and efficient worker with good communication skills.
• The ideal candidate will be an Innovative thinker and problem solver.
• The ideal candidate will be flexible and able to embrace change.
•The ideal candidate will have the ability to make independent decisions with a high degree of initiative. Qualifications
• Bachelor’s degree or greater in a scientific discipline.
• Minimum of 12+ years’ experience in a Quality Assurance role in the pharmaceutical industry.
• Supervisory experience of at least 10 years preferred.
•Specialized knowledge of QA Systems and Compliance, business principles and departmental processes is required.
• Extensive experience in quality management of CMOs and CROs supporting a virtual company is highly preferred.
• Ability to work on complex problems in which analysis of situations or data is required.
• The ability to effectively interact with internal peers and site management to lead continuous improvement is required.
• Extensive knowledge of Drug Product and API GMP requirements and associated guidelines for both the FDA and EU is required.
• Experience in implementation and administration of quality systems for drug product development, clinical and manufacturing and quality control operations is required.
• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues, is required.
• Experience participating in pharmaceutical technology transfer teams is required.
• Experience in the qualification of facilities, utilities, equipment and processes is required.
• Ability to increase others knowledge of US GMP regulations and guidance is required.
• Strong written and oral communication skills are required.
• Ability to manage multiple duties and tasks is required.
• Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others, both within the department and cross-functionally, is required.
• This position is located in South San Francisco and may require 10-20% travel.
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United States-California-South San FranciscoOrganization
Alios BioPharma, Inc. (6224)Job Function