Senior Director, Regulatory Combination Product
Abata TherapeuticsSalary not specified
Senior Manager, Quality – Combination Products, Compliance at Gilead Sciences
La Verne, California, United States
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
- 8+ years of relevant experience with a Bachelor’s degree in a Science or Engineering field; or 6+ years of relevant experience with a Master’s degree in a Science or Engineering field
- Medical device manufacturing, testing or QA experience is essential
- Experience with combination devices (e.g., autoinjectors, co-packaged kits, pre-filled syringes) is preferred
- Demonstrated in-depth knowledge of Quality principles, concepts, industry practices, and standards
Responsibilities
- Monitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulations
- Monitor device/combination product enforcement trends in the industry and develop recommendations and action plans for QMS improvement
- Participate in external industry committees and ensure compliance with applicable medical device and combination product regulations
- Participate in the development and rollout of device standards lists by product types and families
- Coordinate and lead the process mapping and change for the development, revision, and maintenance of applicable department SOP’s, job aids, and WI’s
- Engage with stakeholders across various functions when creating/revising QMS processes
- Lead gap assessments against new regulations and relevant inspectional observations, and perform impact assessments as required
- Participate in evaluations of medical device reports (MDRs) and provide documented justifications for reportable and non-reportable regulatory decisions
- Support medical device and combination product inspectional readiness activities and regulatory inspection responses
- Assist with internal and external audits and inspections, acting as an SME and providing follow-up support as required
- Support combination product complaints process and investigations and relay findings to the design and development team
- Evaluate information from a QA technical perspective to ensure appropriate analysis and risk prioritization
- Compile and analyze data, metrics, and trends associated with combination product processes
- May manage Quality personnel (contract or FTE), including organizing and prioritizing daily tasks, conducting training, and writing performance reviews
Skills
QMS
Combination Products
Medical Device Standards
Global Regulations
Compliance
Quality Management
Vial Kits
Pre-filled Syringes
Gilead Sciences
Develops and commercializes biopharmaceuticals
About Gilead Sciences
Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.
Foster City, CaliforniaHeadquarters
1987Year Founded
$15,873.6MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees