Pyxis is looking for a Quality Assurance Manager who will manage and oversee the Document Control aspects of Quality Assurance and will assist with other QMS responsibilities. The candidate must have a working knowledge of QMS and its responsibilities and be a self-starting problem solver who drives results through high compliance and a positive work style ensuring quality activities are carried out according to the regulatory requirements.
- Work across the organization to engage, integrate functions and ensure compliance within a single QMS system to achieve quality results within the Clinical Operations, Regulatory, CMC/Manufacturing, Supply Chain, Pharmacovigilance, and Non-Clinical functions.
- Review various documents such as notes to file, batch records, deviations, technical reports, analytical data, stability protocols, specifications, validations and other documentation as needed.
- Maintain batch release and CDMO quality metrics to measure and drives process improvements where appropriate. Ensure documentation complies with GXP regulations, industry guidelines and corporate expectations
- Partner cross-functionally to develop, maintain and administer SOPs, guidelines and training materials to meet corporate, industry and regulatory standards
- Lead the quality document control management
- In collaboration with IT support, lead inquiry, assessment, evaluation and recommendation of future electronic management systems.
- Provide support for appropriate process and archiving for non-GxP document management
- Develop and deliver GMP training programs and manage training program (e.g., training curricula, records, files and reports)
- Working with functional and GxP SMEs and qualified auditors, manage the vendor qualification process
- Work collaboratively cross-functionally to engage in proactive relationships with FDA and international regulatory authorities as appropriate and, when required, to present and defend strategies and approaches to facilitate the advancement of the Company’s goals and objectives
- Support GxP training of functional areas and contribute to the development of appropriate training for internal and external personnel
- Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to QA activities
- Drive Document Management System tasks to completion
- Assist in the execution of other QMS responsibilities as needed
- Manage and oversee the Document Management System that would include Edit document formatting without changing content to ensure consistency across documents
- Coordinate workflows with task owners to ensure that documents are properly reviewed, issued, approved, and obsoleted within needed timeframes
- Follow up with others to ensure that records are completed and documented within established timeframes
- Provides regulatory guidance and direction on transfers sourcing, development and manufacturing teams, as well as compliance projects, throughout the product development life-cycle, and identifies/coordinates cross functional deliverables and support for submissions and OUS registrations.
- Provide QA CMC Operations support for end-to-end supply chain coverage. This includes quality & compliance support of manufacturing, testing, packaging/ labeling and distribution activities
- Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
- Other activities as assigned.
- Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
- 5+ years of pharmaceutical industry with Quality Assurance background in a GxP environment, clinical programs ranging from Phase 1-3
- Experience with various QA documentation including batch records and training records
- Demonstrated success in preparation and management of regulatory submissions activities
- Possess a strong quality & compliance background and the ability to communicate effectively in a cross-functional team environment
- Thorough understanding of global regulations
- Strong technical understanding of relevant procedures, practices, and associated terminology
- Thorough knowledge of product development process and design control
- Excellent research and analytical skills
- Ability to manage multiple projects
- Ability to work and problem solve both independently and within a team
- Excellent written and oral communication, technical writing and editing skills
- Completes all necessary training in the area of Quality and GMP
To apply, please send resume to firstname.lastname@example.org