Website Aucta Pharmaceuticals, Inc.
Aucta Pharmaceuticals, Inc. is a technology-based company focusing on the development and commercialization of Branded Specialty Products. Aucta is a pharmaceutical company creating better products of proven molecules using 505(b)(2) regulatory pathway. Through innovation, Aucta is creating new therapeutics, including new dosage forms, new dosing regimens and new indications.
Quality Assurance Manager
- Support the Senior Director of Global Quality Assurance and the QA Department and any applicable internal business units, including – but not limited to – manufacturing, facilities, and Regulatory Affairs; and provide global Quality Assurance strategies for global product development and deployment, including support of regulatory submissions and GMP compliance.
- Have thorough knowledge of cGMP, GxP, FDA guidance, EU Directives, and ICH. Must be familiar with current and emerging US and global guidelines and applicable regulations, including 505(b)(2) regulatory pathway, and apply to the company’s quality management system and risk mitigation strategies.
- Assist in monitoring and overseeing the supplier management program.
- Support risk assessments and root cause analysis to identify audit targets, establish audit plans, conduct internal and third-party audits, develop and maintain audit tools, checklists, and author audit reports and other audit-related documentation.
- Assist with the internal CAPA process and facilitate investigations, deviations, corrective action requests, and exploration of non-conformances for the organization, CMO, laboratories, and other third parties.
- Engage with relevant departmental units to develop appropriate adaptive actions, corrective actions, preventive actions, implementation verification, and effectiveness checks.
- Ensure that corporate policies and any GxP documentation, as well as the contracting manufacturing organizations and laboratories are ready for regulatory authority inspections.
- Support the Quality Training Program for the organization; ensure that training curriculums and training matrices are routinely reviewed and remain current.
- Support the Annual Product Review (APR).
- Assist with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities.
- Other GxP duties, as applicable.
- Bachelor’s Degree in a scientific discipline (Biology, Chemistry, Pharmacy or equivalent) Master’s degree preferred.
- 5 – 8 years of pharmaceutical or biotech industry experience.
- Must have at least 6 years of hands-on Quality Assurance experience for API and finished products in a GMP environment and drug safety.
- CQA certification desired. Experience with overseeing Contract Manufacturing Organizations and contract laboratories is highly desirable as well as leading respective audits is essential.
- Strong working knowledge of FDA and international regulations (ICH, EMA, MHRA, GPV, GCP etc.) and the ability to interpret and apply applicable regulations.
- Experience with regulatory inspections.
- Good organizational skills with the ability to perform multiple tasks efficiently and effectively
- Ability to adapt to a global, fast-paced, matrix, timeline driven environment with the competency to work independently and multi-tasking.
- Strong oral and written communication skills.
- Motivated self-starter who can work independently.
- Strong interpersonal skills with the ability to professionally interact with all levels of personnel.
If you are interested in this position, please email cover letter and resume to：Pedro.Bento@auctapharma.com