About This Role
The Associate Director, Quality Assurance & Governance - R&D Quality & Compliance (RDQC) will provide strategic guidance, oversight and support for the quality activities within the Quality Management System (QMS), including regulatory health inspections and the overall R&D audit management. Partners with other quality and compliance groups across R&D and PO&T functions to enable transparency, escalation and risk minimization of quality and compliance issues. Provides oversight and trending of relevant quality metrics; proactively assessing potential quality risks and recommends mitigating / remediating actions to key stakeholders and quality governance.
What You’ll Do
Who You Are
You have a demonstratable knowledge of GxP regulations and ability to implement these requirements in processes, procedures and systems. You are interested in building your quality expertise, with a key focus on audit management and regulatory inspections. You are adaptable and able to manage competing priorities, with key strengths in communication and problem solving.
Required Skills
Preferred Skills
The base salary range for this position is $163,000 - $225,000. Base salary offered is determined though an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Eurofins Scientific seeks a detail-oriented Quality Assurance Specialist for their environment testing lab in Lancaster, PA to support certification, documentation, and regulatory compliance.
Lead quality system transformations and manage data analytics initiatives at Medtronic’s Diabetes business to enhance healthcare innovation and patient outcomes.
Contribute to automotive software excellence as an Android QA Engineer at General Motors, working on innovative vehicle infotainment systems in a hybrid work environment.
Lead regional food safety and quality initiatives for a fast-growing snack food company, ensuring regulatory compliance and product excellence across multiple facilities.
IXL Learning is hiring a QA Analyst focused on UI and front-end testing to help deliver high-quality educational technology products.
Stryker is looking for a Customer Quality Engineer to drive quality assurance and regulatory compliance activities in their Cary, Illinois facility in a hybrid work setting.
Contribute to JaTango’s mission by ensuring high-quality releases as a QA Engineer specializing in automated end-to-end and manual testing.
An established automotive manufacturer is looking for a dedicated Quality Engineer to lead quality improvement and ensure compliance in a fast-paced, growth-oriented environment near Atlanta, GA.
A Senior Quality Engineer role at Medtronic focused on ensuring quality and compliance in pioneering medical device products within a dynamic healthcare environment.
Lead document control and quality assurance efforts for cGMP compliance at a cutting-edge biopharmaceutical facility supporting government and industry clients.
Contribute as a Software Test Engineer I at Qualtrics, enhancing quality assurance for customer experience products using automation and collaboration.
Drive automation and quality assurance for financial applications at State Street Bank, supporting AML Transaction Monitoring in a hybrid Agile role.
Lead the QA strategy and team at Axon’s VR pillar to ensure top-tier quality across immersive simulation products.
Drive innovation to defeat the most complex and devastating diseases.
297 jobsSubscribe to Rise newsletter