Sr Manager - Quality Compliance
Redwood City
Quality – Quality Assurance /
Full Time /
On-site
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI)
The Sr Manager Quality Compliance position supports and ensures compliance with GxP standards, including Good Clinical Practice (GCP), Good Distribution Practices (GDP), Good Documentation Practices (GdocP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP) and Good Pharmacovigilance Practices (GPvP) as applied to the product lifecycle, from research and development, clinical phases and commercial launch and on-going commercial quality support. This position serves as the in-office Quality presence in the corporate office and will coordinate with quality colleagues working remotely.
Principle Duties and Responsibilities Include:
- Inspection Readiness and Management and Support of Regulatory Inspections (example clinical, preapproval and routine inspections)
- Provide technical quality and/or strategic support to clinical sites and service provider sites to ensure inspection readiness and pre-approval inspections.
- Lead and participate in mock inspections, internal audits, and other readiness activities.
- Lead and support during the preparation, execution, and closure of health authority inspections. Provide the Quality representation in the Redwood City office to receive unannounced health authority inspections.
- Support design, training, and execution of GxP inspection management processes and procedures in collaboration with internal and external teams to ensure a state of inspection readiness. Work internally or externally to manage regulatory inspection responses within required time frames.
Service Provider Program/External and Internal Audits
- Develop and maintain an annual risk-based audit schedule for external service providers. Ensure adherence to the schedule and completion of all required documentation per procedures.
- Lead and maintain periodic review of all service providers.
- Lead GxP Audits, ensuring compliance with applicable regulations/guidelines and quality agreements. Development and implement audit plans/agendas, draft and review audit reports, work with providers for review and acceptance of audit responses.
- Maintain the approved vendor list.
- Negotiate and approve Quality Agreements and related documents.
- Maintain tracking for all arms of the program and report key KPIs.
- Support and manage the GxP internal and audit processes and procedures that govern the programs.
- Evaluate internal and external audit findings and ensure timely identification and escalation of potential critical observations and compliance gaps are escalated to senior leadership. Support the cross functional teams to ensure remediation.
Annual Product Review (APR)
- Formalize APR procedure considering virtual service provider relationships and contracts.
- Develop and manage APR schedule in compliance with regulations. Work with service providers to receive and complete review of APR packages.
- Lead Annual Product Review (APR) activities which include collection and compilation of all relevant data, data analysis, report generation and review and approval of APR report.
General
- General support of all Quality Management Systems and staff.
Requirements
- Bachelor’s Degree required.
- Minimum of 9+ years of relevant experience including auditing, quality systems, and establishing/leading an inspection management programs.
- Is knowledgeable in industry practices, regulations, and guidance and has experience with multiple health authorities (e.g. FDA, EMA, MHRA etc.).
- Demonstrates working knowledge of GxP Quality Management System fundamentals.
- Familiar and has experience with all Quality Systems (i.e. Deviations, CAPA, Change Control, Controlled Documents, Complaints etc.). Can serve as support or back up for other Quality System Functions.
- Demonstrate understanding and impact of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for considerations into the Quality strategy.
- Proven track record of developing and implementing audit and inspection management programs.
- Proven track record of technical writing as applied to quality documentation.
- Is experienced in working in validated systems such Veeva or Trackwise and has understanding of validation methodologies, regulatory compliance (e.g., FDA 21 CFR Part 11, Annex 11), and relevant industry standards.
- Skilled at cross functional collaboration with operational colleagues in clinical and product supply.
- Ability to lead, facilitate and manage cross-functional teams comprised of internal and external stakeholders.
- Brings a high degree of technical competency to bear upon their decision making process, applying innovative approaches and methods to more complex problems possessing greater technical complexity.
- Demonstrates the ability to facilitate multi functional teams to generate analytical data of a high quality and present them coherently to an internal and /or external audience including Regulatory Agencies.
- Acts with a sense of urgency and self-motivated with the ability to demonstrate initiative.
- Exceptional teamwork and collaboration skills with internal and external parties.
- Proficient in MS applications such as Power Point, Word, and Excel.
- Strong presentation skills and an ability to communicate effectively at a variety of levels across the organization.
- Proven ability to think strategically and to translate strategy into actions.
- Willingness to work in a dynamic and changing environment.
- Acts as a role model in living the Rezolute Inc. values
Rezolute (RZLT) currently anticipates the base salary for the Sr Manager Quality Compliance role could range from $165,000 to $180,000 and will depend, in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
Qualifying employees are eligible to participate in benefit programs such as:
· Health Insurance (Medical / Dental / Vision)
· Disability, Life & Long-Term Care Insurance
· Holiday Pay
· Tracking Free Vacation Program
· 401(k) Plan Match
· Educational Assistance Benefit
· Fitness Center Reimbursement
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.
