Senior Manager, Quality Assurance
The Senior Manager, Quality Assurance supports GMP Quality Assurance in maintaining Quality Systems related to clinical development, manufacture and testing of clinical supplies and future commercial product for Venatorx. The Senior Manager, Quality Assurance ensures the Quality Systems are maintained, including control over the documentation required for regulatory submissions. The position also participates in and contributes to oversight of manufacturing/testing operations at third party organizations.
- Maintain GMP compliance for Venatorx programs to support clinical studies and future product registration.
- Support the development and implementation of quality systems to ensure product reliability, quality, efficacy, and compliance to applicable Venatorx SOPs, GMP regulations and applicable country specific standards
- Provide GMP Quality Assurance oversight of vendors
- Manage the compliance (GMP) auditing program to fulfill regulatory requirements.
- Write and review GMP Standard Operating Procedures
- Responsible for reviewing batch manufacturing records, clinical packaging records, associated batch record documents, validation protocols and reports
- Responsible for reviewing and tracking internal and contract organization OOS, deviations, change controls, and product complaint investigations
- Assist with ensuring CAPA findings from GMP audits and regulatory inspections are effectively addressed and closed
- Provide expertise and guidance to Venatorx departments in interpreting and implementing governmental and agency guidelines to assure GMP compliance.
- Follow applicable regulations, including FDA, ICH, GMP, and Venatorx policies and procedures.
- Represent QA at CMC project team meetings and contract organization meetings
- Provide Quality support to overall product Stability Programs
- Perform Quality Review of Regulatory Submissions
- Participate in internal and external audits
- Participate in regulatory inspections
- BS in Chemistry, Chemical Sciences, Biochemistry or equivalent education and experience
- 5-7 years of relevant and current work experience in pharmaceutical industry, Quality Assurance required.
- Previous experience working with contract facilities (laboratories, manufacturers, packagers, distributors, and wholesalers)
- Experience with developing relationships and influencing performance outcomes by external partners
- Ability to work under challenging deadlines and be accountable for completing work within specific project timelines
- Strong detail orientation, organization and focus on quality work product
- Proficient in MS Office Suite, Quality systems, electronic document management systems (eDMS)
- Proven ability to establish new quality systems and optimize existing systems, review documentation, processes and procedures, identify issues, assess compliance, communicate findings clearly and succinctly
- Excellent verbal and written communication skills
- Demonstrated technical and analytical thinking in resolving issues of critical importance
Equal Employment Opportunity/M/F/disability/protected veteran status