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Project Management Jobs in Foster City, CA

Project Manager

Leadstack Inc

Foster City, CA

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JOB DETAILS
SALARY
$80–$100 Per Hour
SKILLS
Biotech and Pharmaceutical, Change Control, Change Management, Contract Management, Contract Manufacturing, Cross-Functional, Current Good Manufacturing Practice (cGMP), Document Management, Documentation, Drug Development, Drug Products, File Maintenance, Fortune 500 Customers, Manufacturing, Manufacturing/Industrial Processes, Medical Equipment, Product Control, Product Management, Project/Program Management, Regulations, Risk, Risk Management, Surveillance, Time Management
LOCATION
Foster City, CA
POSTED
30+ days ago
LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title : Project Manager
Location: Hybrid - Foster City, CA 94404
Duration: 18 Months
PR: $80/hr - $100/hr on W2
 
Description:
The Device Engineering team at Gilead is seeking a qualified individual to support drug device combination products throughout the commercial lifecycle. This individual will be responsible for the management of combination product change records. Additional responsibilities include post market surveillance reports, risk management file maintenance, and general project management across the combination product portfolio.
 
Job Responsibilities
· Coordinate and manage combination product change control records –
o Initiate, route, and close change records for product and manufacturing process changes.
o Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation.
o Manage implementation of changes at multiple manufacturing sites and change record closures.
· Coordinate post-market surveillance reports and risk management file updates –
o Collate surveillance information into yearly reports.
o Generate annual risk summaries and update risk management files.
· Support complaint investigations and documentation.
· Act as a central hub between cross-functional teams to ensure supply continuity.
 
Knowledge & Skills
· Exceptional organizational and time management skills.
· Understanding of change controls in a regulated industry.
· Experience with project management.
· Working knowledge of relevant US, EU, and international medical device and pharmaceutical regulations.
· Experience with Veeva Vault.
· Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.
 
Education & Experience
· 3 – 5 years relevant experience in related field and a BS or BA.
· Experience with medical device development and / or pharmaceutical operations (cGMP environment) required.
 
If you have any questions, feel free to call me on (415) 322-5419or send an email on

akarsh.yathiraj@leadstackinc.com


 
Thanks and Regards
Akarsh Yathiraj
Senior Recruiter
 
C.(415) 322-5419
D.(415) 322-5419
A.611 Gateway Blvd, Ste 120
South San Francisco, CA 94080
W.www.leadstackinc.com

About the Company

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Leadstack Inc

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