Quality Director Jobs

About The Position

Requirements

• Advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
• Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.
• Ability to collaborate cross functionally to drive operational and quality excellence.
• Advanced organizational and time management skills.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Advanced teamwork and facilitation skills.
• Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
• Requires strategic thinking and ability to work independently.
• Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
• Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.
• Ability to interpret and author general, technical, and complex business documents.
• Advanced knowledge and implementation of data integrity principles.
• Ability to represent the department in regulatory inspections.
• Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.
• Proficiency in MS Office applications.
• Ability to develop and manage a departmental budget.
• Ability to manage headcounts.
• Ability to lead projects to completion.
• Ability to design microbiology laboratory space and drive lean lab initiatives.
• Knowledgeable about micro assays including endotoxin, mycoplasma, rapid sterility method, automated EM plate reads
• Bachelor’s degree required, preferable in Chemistry, Microbiology, or related science.
• 10 years of relevant work experience required. Higher education may be counted towards work experience.
• Leadership experience with direct reports required.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• Manages all activities related to the Quality Control Microbiology department including: Stability testing, Raw material, in-process, and final product testing, Environmental Monitoring, Method validations/maintenance, Metrics/data analysis, Investigations
• Manages and develops direct reports including: Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.
• Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.
• Performs other tasks as assigned.

Benefits

• wellbeing support
• retirement and financial protection benefits
• insurance offerings (medical, dental, vision, life and disability)
• Flexible Time Off (FTO)
• 11 paid company holidays each year
• 160 hours of paid vacation annually for new hires
• 3 optional holidays
• paid sick leave
• up to two paid volunteer days per year
• summer hours flexibility
• leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
• annual Global Shutdown between Christmas Day and New Year's Day