Executive Director, CMC Quality Assurance
Abata TherapeuticsSalary not specified
Full Time
Expert & Leadership (9+ years), Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Experienced, dynamic, and results-driven leader for Sr. Director level role
- Ability to provide strategic and hands-on quality oversight of GMP activities
- Expertise in GMP regulations, guidelines, and standards
- Capability to collaborate closely with internal stakeholders (e.g., CMC, Regulatory, Supply Chain, Quality Control) and external partners (e.g., contract service providers)
- On-site availability in South San Francisco
Responsibilities
- Provide strategic and operational quality oversight of GMP activities, including drug substance and drug product manufacturing, analytical testing, release, labeling, packaging, and distribution
- Ensure all manufacturing and testing operations are conducted in compliance with applicable GMP regulations, guidelines, and Septerna standards
- Review and approve key GMP documents, including master batch records, validation protocols, stability protocols, deviation investigations, and change controls
- Conduct audits of contract manufacturing, testing, and related service providers to verify compliance with GMP, data integrity, and Septerna quality expectations
- Establish and periodically review Quality Agreements with Septerna’s Contract Service Providers to define and maintain clear quality responsibilities
- Develop, track, and trend GMP Quality Metrics to monitor product quality, identify areas for improvement, and drive compliance performance
- Partner with CMC, Regulatory, Supply Chain, and Quality Control teams to ensure manufacturing and testing readiness for clinical and future commercial programs
- Evaluate the performance and quality systems of contract manufacturing and testing partners through audits, periodic reviews, and ongoing oversight
- Support vendor qualification and risk-based quality oversight to ensure compliance and product quality throughout the supply chain
- Provide guidance (on GMP quality assurance matters)
Skills
GMP
Quality Assurance
GPCR
Drug Discovery
Biotechnology
Preclinical Research
Regulatory Compliance
Superna
Data protection solutions for Dell EMC Isilon
About Superna
Superna Eyeglass provides data protection solutions specifically designed for Dell EMC Isilon storage systems. Their products include tools for data replication, disaster recovery, and compliance auditing, which help enterprise clients manage their data securely and efficiently. The software operates on a subscription model, allowing clients to receive regular updates and technical support. What sets Superna Eyeglass apart from competitors is its focus on the unique needs of Dell EMC Isilon users, enabling them to offer specialized services in the data protection market. The company's goal is to ensure that clients can maintain secure operations while meeting compliance requirements.
Ottawa, CanadaHeadquarters
2002Year Founded
BUYOUTCompany Stage
Data & Analytics, Enterprise SoftwareIndustries
51-200Employees
Risks
Emerging startups offer innovative solutions at lower costs, threatening market share.
Cloud-native solutions may outpace Superna's current offerings, reducing attractiveness.
Vulnerability in Dell EMC Isilon systems could impact client trust if not addressed.
Differentiation
Superna Eyeglass specializes in Dell EMC Isilon storage systems, carving a niche market.
The company offers a subscription model, ensuring ongoing software updates and support.
Superna provides tailored solutions for data replication, disaster recovery, and compliance auditing.
Upsides
Rising demand for hybrid cloud solutions boosts Superna's market potential.
New data privacy regulations increase demand for compliance auditing tools.
Ransomware threats drive demand for robust disaster recovery solutions.
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