What are the responsibilities and job description for the Sr. Director, Quality Operations and Inspection Management position at BridgeBio?
About Calcilytix & BridgeBio Pharma
Calcilytix Therapeutics , an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluated in a Phase 3 clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30 drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aims to translate today's discoveries into tomorrow's medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
To learn more about our story and company culture, visit us at https : / / calcilytix.com / | https : / / bridgebio.com
Who You Are
The Sr Director, Quality Operations and Inspection Management is responsible for managing GCP and GVP inspections and assisting the organization with developing and continuously improve processes and systems. This position requires strong judgement skills and business acumen in order to advise internal and external key stakeholders on interpretation and compliance with international regulations / guidelines; corporate policies; and standard operating procedures (SOPs).
Responsibilities
- Manage GCP and GVP Inspections :
Partner with internal and external key stakeholders to ensure assigned BridgeBio affiliate is inspection-ready
Manage inspection readiness meetings and timelines; coordinate mock inspections; and conduct inspection readiness trainings
Facilitate R&D SOP review and approval process within QA and across functional areas
No matter your role at BridgeBio, successful team members are :
Education, Experience & Skills Requirements
What We Offer
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
225,000-$280,000 USD
Salary : $225,000 - $280,000
