Quality Regulatory Program Manager

GeneFab; Alameda (CA); Presencial; USD 180.000 - 280.000; Jornada completa

Descripción de la vacante

GeneFab is seeking an experienced Quality Regulatory Program Manager to lead quality assurance and regulatory initiatives, ensuring compliance with regulatory requirements and driving continuous improvement for patient safety. This on-site role in Alameda, CA collaborates with clients and CROs to develop strategies for successful registrations and lifecycle management of complex products.

You will oversee submissions to regulators, prepare briefing materials, and manage interactions with

Formación

• Bachelor’s degree in a scientific discipline.
• 10+ years in compliance, quality, and CDMO/CMO management with regulatory lifecycle experience.
• 10+ years GMP/QA experience.
• Knowledge of aseptic manufacturing processes.
• Broad knowledge of FDA and international regulations related to GMPs and Biopharma.
• Experience with inspections by global regulatory agencies (FDA/EMA).
• Regulatory requirements across development stages and post-approval.
• Strong communication and project management skills.
• Ability to lead cross-functional teams.

Responsabilidades

• Plan, prepare, and manage submissions to regulatory authorities with client collaboration.
• Prepare briefing materials for HA meetings and coordinate SMEs.
• Engage regulators and manage follow-up.
• Communicate regulatory strategy to stakeholders and senior management.
• Manage regulatory registrations and licenses (FDA, Oregon Board of Pharmacy).
• Develop and implement a comprehensive QA strategy aligned with goals and regulatory requirements.
• Provide strategic direction to the QA team and promote a culture of quality.
• Collaborate with cross-functional teams to integrate quality into manufacturing processes.
• Foster awareness of quality principles throughout the organization.
• Provide phase-appropriate regulatory guidance for trials and marketing applications.
• Collaborate with clients, consultants and CROs for appropriate regulator interactions.
• Manage the QA budget to ensure on-time, on-budget project delivery.
• All other duties as assigned.

Conocimientos

Regulatory strategy

Quality improvement

Cross-functional collaboration

Project management

Communication skills

Negotiation

Leadership

Educación

Bachelor's degree in science

Herramientas

Regulatory submissions software

Descripción del empleo

About the role

We areseekingan experienced and dynamicQuality Regulatory Program Managerto lead our quality assuranceregulatoryinitiatives. As theProgram Manager, you willbe responsible forensuring compliance with regulatory requirements,maintaininghigh-quality standards in manufacturing processes, and driving continuous improvement initiatives to enhance product quality and patient safety.This key role will develop and implement regulatory strategies leading to successful registration and life-cycle management of complex products serving patients and clients. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.

This role is based on-site in Alameda, CA.

What you'll do

• Plan, prepare, and manage submissions to HAs including, INDs, NDA/BLA regulatory filings in strong collaboration withGeneFab'sclients.

• Participate in regulatory interactions with HAs including managing preparation of briefing materials for HA meetings, preparing subject matter experts (SMEs), and ensuringappropriate follow-up.

• Participate in negotiations with regulatory agencies to resolve and review issues and shepherd proactive interactions with regulators.

• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs, programteamsand senior management, as relevant

• Prepare and manageGeneFab'sregulatory registrations and/or licenses (e.g., FDA, Oregon Board of Pharmacy).

• Develop and implement a comprehensive quality assurance strategy aligned with the organization's goals and regulatory requirements.

• Provide strategic direction and leadership to the Quality Assurance team, fostering a culture of quality excellence and continuous improvement.

• Collaborate with cross-functional teams to integrate quality principles into all aspects of the pharmaceutical manufacturing process.

• Foster a culture of quality and compliance by promoting awareness and understanding of quality principles throughout the organization.

• Independently provide effective phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for projects.

• Work in close collaboration with clients, consultants and/or CROs, as needed, to ensure appropriate interactions with HAs.

• Manage the QA budget to ensure that resources areallocatedappropriately and that all projects are completed on time and within budget.

• All other duties as assigned.

Qualifications

• Minimum of a bachelor's degree, preferably in a scientific discipline.

• A minimum of10years of experience in compliance, quality, andCDMO/CMO management with a focus on regulatory documentation and lifecycle management.

• Minimum of10years of GMP/QAexperience.

• General knowledge of aseptic manufacturing processes.

• Broad knowledge of FDA and international regulations related to GMPs and Biopharma.

• Experience organizing and managing work responsibilities while working independently with minimal oversight.

• Time and project management skills with the ability to multi-task and meet deadlines.

• Excellent verbal and written communication skills.

• Excellent interpersonal and customer service skills.

• Excellent organizational skills and attention to detail.

• Broad knowledge of FDA and international regulations related to GMPs andBioPharma.

• Experience organizing and managing work responsibilities while working independently with minimal oversight.

• Knowledge of GMP requirements and quality regulations within the Biopharma industry, backed by extensive experience in preparing for and successfully navigating inspections conducted by global regulatory agencies, including the FDA and EMAauthorities.

• Experience with drug substances and drug products is desired.

• Knowledge of regulatory requirements across development stages and post-approval is essential.

• Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.

• Strong strategic and analytical abilities, diplomacy, and negotiation skills.

• The ability to collaborativelyinfluencesmultiple functions andmotivatesothers toaccomplishcompanyobjectives.

• Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities.