Quality Compliance Manager overseeing compliance implementation and project management in medical device industry. Strong experience in Quality Management Systems and cross - functional collaboration is required.
About the role
- Associate Director leading CMC regulatory strategies for hematology and oncology portfolios. Mentoring staff and guiding regulatory activities while collaborating with cross-functional teams.
Responsibilities
- lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios
- guide regulatory activities across development stages, mentor CMC Regulatory Affairs staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions
- lead product development activities from a CMC regulatory standpoint with input from senior management
- represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities
- identify program issues and develop appropriate regulatory strategies to mitigate risks to filings
- critically review and provide meaningful and strategic input on regulatory filing documents to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics
- lead and facilitate interactions with global regulatory authorities
- perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings
- mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management
- develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups
- identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency
- support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field
- manage and coach team member(s)
Requirements
- a bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience
- an advanced degree is preferred
- proven track record supporting small molecule drugs and/or biological products through development and approval
- experience in interacting with the US FDA and other regulatory authorities
- experience with device regulatory requirements and development processes for combination products is a plus
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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