Quality Regulatory Program Manager

GeneFab•Alameda, CA

46d•Onsite

About The Position

GeneFab is seeking an experienced Quality Regulatory Program Manager to lead quality assurance and regulatory initiatives. The role ensures compliance with regulatory requirements, maintains high-quality manufacturing standards, and drives continuous improvement to support product quality and patient safety. The manager develops and implements regulatory strategies for registration and lifecycle management of complex products, building partnerships with stakeholders and aligning execution with business priorities. This position is based on-site in Alameda, California.

Requirements

Bachelor’s degree or higher; a scientific discipline is preferred.
At least 10 years of experience in compliance, quality, and CDMO/CMO management, with a focus on regulatory documentation and lifecycle management.
At least 10 years of GMP/QA experience.
General knowledge of aseptic manufacturing processes.
Broad knowledge of FDA and international GMP and biopharmaceutical regulations.
Knowledge of GMP requirements and quality regulations in the biopharmaceutical industry, supported by extensive experience preparing for and navigating inspections by global regulatory agencies, including the FDA and EMA.
Knowledge of regulatory requirements across development stages and after approval.
Expert working knowledge of the full drug development process and FDA and ICH regulatory requirements.
Ability to organize and manage responsibilities independently with minimal oversight.
Time and project management skills, including the ability to multitask and meet deadlines.
Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills.
Excellent organizational skills and attention to detail.
Strong strategic and analytical abilities, diplomacy, and negotiation skills.
Ability to influence multiple functions collaboratively and motivate others to accomplish company objectives.
Self-motivated, detail-oriented, and able to exercise sound judgment and innovative thinking when addressing challenges and opportunities.

Nice To Haves

Experience with drug substances and drug products is desired.

Responsibilities

Plan, prepare, and manage Health Authority (HA) submissions, including IND, NDA, and BLA filings, in collaboration with GeneFab’s clients.
Participate in regulatory interactions with HAs, including managing briefing materials for HA meetings, preparing subject matter experts, and ensuring appropriate follow-up.
Negotiate with regulatory agencies to resolve issues and lead proactive interactions with regulators.
Communicate regulatory strategy, risks, mitigations, and plans to Regulatory Affairs, program teams, and senior management as appropriate.
Prepare and manage GeneFab’s regulatory registrations and licenses, such as FDA and Oregon Board of Pharmacy registrations or licenses.
Develop and implement a comprehensive quality assurance strategy aligned with organizational goals and regulatory requirements.
Provide strategic direction and leadership to the Quality Assurance team, fostering quality excellence and continuous improvement.
Collaborate with cross-functional teams to integrate quality principles throughout pharmaceutical manufacturing.
Promote organization-wide awareness and understanding of quality principles and compliance.
Provide independent, phase-appropriate strategic guidance on current regulatory requirements and expectations for clinical trial and marketing applications.
Work with clients, consultants, and/or CROs as needed to ensure appropriate interactions with HAs.
Manage the QA budget and allocate resources to complete projects on time and within budget.
Perform other duties as assigned.