Quality assurance engineer Jobs in Springfield, MA

Director / Sr. Director, Quality Assurance

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 Director / Sr. Director, Quality Assurance is responsible for executing the Good Clinical Practice (GCP) Quality and Compliance program at BridgeBio. It 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). This individual will also be an active participant in regulatory inspections.

Responsibilities

• Support internal and external GCP audit program
• Lead 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 quality 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
• Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed

Where You'll Work

Who You Are

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 :

Health & Wellbeing :

Skill Development & Career Paths :

Salary

$230,390.33 - $262,736 USD