Published: February 15, 2021
- Direct management of on-the-floor QA activities including but not limited to oversight of the inspection, labeling and packaging processes, batch record review, deviation investigation, change controls and SOP revisions, among others.
- Resolve critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting as needed. Identifying also diverse, qualified successors for key positions.
- Strong collaboration and partnership cross functionally (i.e. Manufacturing, Process Development, Regulatory, etc.) to ensure the Quality Management System processes are executed in accordance with established procedures. Ensuring production in full cGMP compliance.
- Strategic advisor to senior management of quality, compliance, supply, and safety risks.
- Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities.
- Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement.
- Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages.
- Bachelor’s Degree in Quality or Manufacturing Experience in GMP regulated environment
- 8+ years of Quality experience
- Bilingual (Spanish & English)
- Validated expertise in Quality Systems such as Non-Conformance, CAPA and Change Control
- Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency)
- Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
- Strong organizational, project management and change management skills
- Ability to motivate staff and manage and distribute workloads
- Demonstrate ability to interact with regulatory agencies
- Solid word processing, presentation, database and spreadsheet application skills