Manager, Quality Assurance, Product Complaint

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

What You’ll Do

The Quality Assurance Manager, Product Complaint, will report to the Sr. Manager, QA, Product Complaints. This position will manage product quality complaints for commercial marketed products and clinical trial materials. The position will ensure compliance with the current regulated standards and internal procedures. This position will require strong cross-functional collaboration with internal stakeholders and external parties.  

Responsibilities

• Maintain and continuously improve global processes related to complaint handling, mock recalls, recalls, and notifications 
• Ensures timely complaint initiation, investigation/analysis, reportability assessments, and reporting to appropriate domestic and international governments as required, and complaint closures 
• Perform monthly reconciliation, trend reports and metrics for Complaints to identify potential quality issues 
• Coordinate with SMEs to ensure all product complaint investigations are completed with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, including appropriate corrective actions, and follow the company’s standards 
• Collaborate with departments (e.g. Affiliates, Manufacturing /Packaging sites, Vendors) to establish appropriate, efficient, and timely investigation strategies 
• Collaborate with key stakeholders to foster effective interdepartmental and cross-functional partnership 
• Escalate to management of potential quality or regulatory issues that may affect product quality or regulatory compliance 
• Participate in audits and regulatory inspections 
• Establish work priorities to meet targets and timelines and effectively manage competing priorities with minimal escalations 
• Serve as the Quality representative in cross-functional and multi-site teams 
• Other duties as assigned  

Where You’ll Work

This is a hybrid role and requires in-office collaboration 2-3x per week, or as needed, in our San Francisco, CA office. 

This position can also be considered for a U.S.-based remote role that will require quarterly, or as needed, visits to our San Francisco Office. 

Who You Are

• Bachelor’s degree or equivalent in operations, science, mathematics, or engineering required 
• A minimum of 5+ years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained 
• Extensive knowledge of US, European and Global product quality complaint handling requirements, and associated guidelines 
• Experience with implementing and maintaining pharmaceutical quality management systems 
• Excellent analytical and critical thinking skills, with keen attention to detail 
• Proficiency in eQMS, Microsoft Office, Google Docs, etc. 
• Experience with commercial marketed products 
• Ready to embrace companies core values and diverse corporate culture 

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

• Financial Benefits:
• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office 

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities