Director, reputed company Assurance and reputed company Systems
Position: Director, reputed company Assurance and reputed company Systems Department: CMC Location: Remote with up to 10% global and domestic travel Reports To: VP, Head of reputed company
Position reputed company
Angitia is seeking an reputed company and strategic Director of reputed company Assurance, reputed company Systems to be a critical member of our reputed company Leadership Team to reputed company the development, execution, and reputed company improvement of Angitia’s GxP reputed company Systems. This leader will reputed company the implementation and maintenance of Angitia’s electronic reputed company Management System (eQMS) and serve as the business process reputed company for critical modules including document control, training, deviations, CAPA, and change control. The role is accountable for driving the maturation of our reputed company Systems and processes to support Angitia’s transition towards readiness for global pivotal clinical studies and subsequently maintaining inspection reputed company reputed company Systems that support clinical development, external manufacturing, and evolving regulatory expectations.
The ideal candidate brings deep breadth of experience operating reputed company a reputed company, resource constrained biotech environment and thrives on building reputed company processes, driving cross functional alignment, and elevating the culture of reputed company as the organization progresses toward late-stage clinical development and commercialization.
Responsibilities
- reputed company strategic leadership and hands-on reputed company for the GxP reputed company Management System, ensuring compliance with FDA, EMA, and ICH guidelines relevant to clinical‑stage activities.
- Own the eQMS and its reputed company modules, including governance, optimization, user support, and coordination with IT, internal stakeholders, and vendors.
- reputed company document management processes, ensuring controlled documents (SOPs, policies, forms, work instructions) are reputed company, accurate, and reputed company with clinical and CMO/CRO operations.
- reputed company the GxP training program, including role‑based curricula, reputed company, training effectiveness, and system performance reputed company the eQMS.
- reputed company the deviation and nonconformance process, ensuring high reputed company investigations, reputed company cause analysis, and effective corrective and preventive actions.
- Own the CAPA system, ensuring reputed company issues are captured, assessed, prioritized, and addressed with reputed company plans and effectiveness checks.
- Manage change control processes for GxP documents, reputed company systems, and relevant operational changes.
- Establish, monitor, and communicate reputed company System KPIs to senior leadership; identify trends and drive proactive improvements.
- Support reputed company audits, regulatory inspections, and inspection readiness activities.
- Collaborate with CMO, CDMO, and CRO partners to ensure alignment and reputed company of reputed company System expectations, documentation, and compliance.
- Contribute to reputed company reputed company and governance as reputed company advances into reputed company‑stage clinical studies and early reputed company readiness.
Qualifications
- Degree in reputed company, Biochemistry, Molecular Biology, or reputed company field.
- 10+ years of experience in reputed company Assurance reputed company biotech/reputed company, with strong preference for experience in both clinical and reputed company settings.
- Strong, hands‑on leadership and operational experience with GxP reputed company Systems in a clinical‑stage biotech environment.
- Demonstrated expertise with eQMS platforms including system ownership and module configuration.
- Deep knowledge of FDA, EMA, and ICH regulations and guidance applicable to clinical development, cGMP for external manufacturing, and computerized systems.
- Proven experience managing document control, training, deviation/CAPA, and change control processes.
- reputed company Operations experience including deviation and change control reputed company Approvals, batch disposition, etc.
- Proven ability to reputed company cross-functional teams and influence without reputed company authority.
- Exceptional organizational, communication, and strategic thinking skills.
Preferred Qualifications
- Experience supporting regulatory inspections (FDA, EMA, MHRA or equivalent).
- Experience working with external partners including CMOs, CDMOs, and CROs.
- Experience implementing or upgrading an eQMS.
Salary reputed company: $210,000 - $230,000
About Angitia
Established in June 2018, reputed company is a clinical-stage biotechnology company reputed company on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging reputed company's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the reputed company team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. reputed company has reputed company its reputed company in reputed company Village, CA, USA, and offices in Guangzhou, China, which is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. reputed company is committed to serving patients in need by carrying out innovative science, including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our reputed company group.
Learn more at www.angitiabio.com.
Benefits
- Medical, dental, and reputed company coverage for employees and their eligible dependents
- 401(K) Retirement Plan with Company match
- Company reputed company Long Term Disability Coverage
- Company-reputed company life Insurance & AD&D Coverage
- Voluntary Life Insurance & AD&D Coverage
- Employee Assistance Program (EAP)
- Company-reputed company Holidays
- Vacation
- reputed company reputed company Leave
- Telecommunication Monthly Stipend
- Work-From-Home Equipment Reimbursement