The Quality Assurance Manager will be responsible for supporting the organization by ensuring conformance to established quality assurance processes and standards while actively working to continuously improve them. This position reports directly to the Director of Quality in the QA organization. Primary responsibilities of this position include support for all aspects of process development, clinical manufacturing, testing and release of drug substance and drug product, collaboratively partnering with and effectively managing multiple pharmaceutical contract manufacturing and testing sites. Additionally, this position will work to maintain and grow all Internal Quality Systems including, but not limited to training, documentation, external and internal audits, deviations, OOT/OOS, and CAPA. Activities to include working hand in hand with Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories (CTL) regarding review of Batch Records and Testing Data. Additional duties include, assisting in review of Regulatory Submissions, Clinical and Nonclinical protocols, reports and associated data and providing general quality assurance support for the overall Quality System in place at Allena.
Who are we looking for?
- An energetic professional who uunderstands regulatory standards and requirements and performs all activities within their confines
- A resourceful, self-starter and team player with a strong results orientation
- A quality-minded person with ability to perform work with detailed accuracy and in accordance with established procedures
What are we looking for?
- A driven professional who knows how to work and contribute to an energetic working environment.
- Knowledge of ICH guidelines and US FDA and EU regulations regarding pharmaceutical manufacturing and testing
What are we offering?
- Membership within a growing, CARING and collegial organization
- An opportunity to grow with the Quality group
- Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
- Review and approve contract manufacturing master batch records in support of drug substance and drug product release
- Review of executed manufacturing batch records in support of drug substance and drug product release
- Final disposition of drug product and drug substance
- Support Allena contract manufacturing sites during batch production, ensuring unexpected events are handled compliantly
- Review and approve standard operating procedures and process validation protocols and reports
- Review and approve documents associated with deviations, investigations, OOS/OOT results, and CAPA action plans
- Review process development and analytical technical reports and verification/review of associated data
- Assist in authoring and review of general QA/QC SOPs
- Initiate/review action reports or deviation reports for any applicable nonconformance
- Build on relationships with Quality Assurance partners at CMOs and CTLs ensuring quality issues are tracked and resolved in a timely manner
- Track and trend batch execution at CMOs, providing periodic updates to Management – alignment to target Turnaround Times and Disposition dates, number of comments and deviations per batch
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
- Engage in activities to continuously assess and improve lot review and disposition processes
- Review of Clinical protocols, reports and associated data
- Review of Investigational Brochures, Informed Consents and other GCP documentation support Clinical Development
- Review of Nonclinical protocols, reports and associated data
- Review of GLP documentation to support Nonclinical Development
- Ensure all documentation complies with GMP, GCP, and GLP regulations and industry guidelines
- Support the development, implementation, and revision of corporate quality systems
- May review and approve other GMP, GLP or GCP documents associated with the manufacture, testing, packaging, labeling of drug substance and drug product as needed
- May serve on project teams
- Support review of CMC, Clinical and Nonclinical updates for regulatory filings including but not limited to INDs and IND annual reports
- Understanding and support of various development phases of new products with respect to early phase and clinical stability studies.
- Anticipate regulatory consequences – develop and maintain knowledge of the history, manufacture, and materials of assigned products and product lines in order to assess the consequences of changes in manufacture, materials or marketing of the product.
- Interact with internal and external auditors as well as external customers or functional groups. May be required to act as spokesperson or subject matter expert on behalf of company.
- Responsible for providing continued evaluation of current processes and procedures for the Quality Assurance program and recommending improvements to management.
- May recommend cost improvements and provide advice on routine operational procedures as related to Quality Assurance
Education and Experience:
- B.S. or M.S. in Chemistry or other related scientific field
- Minimum of 7 years of work experience in pharmaceutical QA and/or QC required
- High proficiency with MS Excel & Word necessary
- Must be familiar with the relevant standards and regulatory requirements (ICH, GMP, etc.)
- Knowledge of manufacturing processes for solid oral dosage forms
- Knowledge of biotechnology-derived pharmaceuticals
- Previous experience working with and managing pharmaceutical vendors/collaborators
- Auditing experience and/or ASQ Audit Certification
- Participation in regulatory agency inspections and/or submissions