Provide direction and leadership for the development and implementation of systems that assure consistent application for a given quality system.
Lead personnel in the application of Quality Assurance policies, procedures, projects, product launches, systems and may be required to assist with complaint handling based on business needs.
Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
Develop staffing requirements. Supervise/manage a combination of exempt and nonexempt employees and ensure training and development plans are current and executed.
Make independent compliant decisions based on knowledge of regulatory requirements.
Initiate, manage, and execute projects to continuously improve the overall effectiveness of the department.
Manage various departmental projects, area metrics, and KPIs.
Minimize Data Integrity errors within a quality system and assure GMP documentation standards.
Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
5+ years' experience in quality assurance, quality oversight or relevant experience.
1-3 years Supervisory experience, quality assurance experience preferred (solid understanding of GxP requirements)
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
Project management experience-strong leadership ability, communicate quality requirements effectively and timely. Runs and manages small to medium sized quality related projects.
Strong oral and written communication skills (with all levels of management) needed.
Excellent interpersonal skills a plus.