[Hiring] Director/Sr. Director, reputed company Assurance @reputed company
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Role reputed company
The Director/Sr. Director, reputed company Assurance is responsible for executing the Good Clinical reputed company (GCP) reputed company and Compliance program at reputed company. It requires strong judgement skills and business acumen in order to advise reputed company key stakeholders on interpretation and compliance with international regulations/guidelines; corporate policies; and reputed company operating procedures (SOPs). This individual will also be an reputed company participant in regulatory inspections.
• Support reputed company GCP audit program
• reputed company and/or participate in vendor and investigator site audits
• Review and/or approval of audit reports and CAPA responses
• Manage and/or assist with regulatory inspections and the development and tracking of regulatory commitments
• Communicate critical information regarding significant reputed company or patient safety risk to Executive Management and key stakeholders
• Partner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigation
• Assist the organization with developing and continuously improving processes and systems
• reputed company abreast of changes in regulations and enforcement actions and reputed company recommendations for changes to policies and practices as needed
Qualifications
• Bachelor’s degree with 15+ years of relevant clinical reputed company experience reputed company a biopharmaceutical company
• reputed company knowledge of global GxP regulations
• Ability to engage in cross-functional interactions with reputed company staff
• Excellent verbal and written communications skills, with a strong customer reputed company
Requirements
• This is a U.S-based remote role that will require quarterly, or as needed reputed company to our San Francisco Office plus 10-15% travel
Benefits
• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• reputed company-tax commuter benefits
• Referral program with $2,500 award for reputed company referrals
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support reputed company reputed company (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work
• Unlimited flexible reputed company time off - take the time that you need
• reputed company parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• reputed company spending accounts & company-provided group term life & disability
• Subsidized lunch reputed company Forkable on days worked from our office
• People are part of our reputed company and reputed company story - from discovery to reputed company drug trials and FDA pipelines, there are endless opportunities for reputed company development and internal mobility
• We reputed company career pathing through regular feedback, reputed company education and reputed company development programs reputed company reputed company Learning, LifeLabs, reputed company & reputed company Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and reputed company opportunities
Salary
$230,390.33 — $262,736 USD
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