Lead the development, design and maintenance of the Quality Management System at the Bayview site with the goal of maximizing efficiency, effectiveness and compliance with all applicable GxP regulations through proactive planning, high-quality training programs, and value-added internal and external audit processes.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Develop and maintain a Site Quality Management System, including the Site Quality Manual, and provide an on-going assessment of Quality Management System effectiveness via Quality Management Review and other established monitoring programs / processes.
- Develop and maintain measures for the Cost of Quality / Cost of Poor Quality and provide routine status reports to management.
- Identify, prioritize, and execute quality improvement efforts to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations. This may include leading system / process engineering or redesign efforts, as required.
- Engage and enable the development of site objectives (e.g., annual improvement priorities), ensuring that Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.
- Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics
- Identify compliance gaps and improvement opportunities to inform the Site Quality Plan and/or Inspection Readiness plans
- Lead the Internal Audit program, including oversight of audit schedules, plans, and follow-up according to internal procedures, regulatory guidance / expectations, and auditing best practices in alignment with Global Compliance policies, procedures, and standards.
- Lead and provide oversight of the CAPA system, ensuring clear root causes are identified and addressed with robust corrective actions, and where appropriate, global actions to prevent reoccurrence of the event
- Ensure that actions are assessed for effectiveness post-implementation.
- Oversight for site-wide GMP training programs, ensuring a clear line of sight from training requirements to specific GMP job functions aligned to job descriptions.
- Oversight of the Regulatory Inspection program, including coordination of activities for regulatory inspections (announced or unannounced), reviewing / preparing documentation demonstrating prior commitments were met, identifying areas of potential vulnerability and communicating / mitigating accordingly, and managing logistics for hosting an audit / inspection.
- Coordinate response activities following regulatory inspections including drafting responses, periodic updates (as required), and ensuring adequate follow-up on suggestions for improvement (e.g. FDA EIR notes, recommendations, etc.) within the site quality system.
- Oversee and coordinate the Client Audit Program, facilitating schedules, audit activities and coordinating and communicating audit response letters.
- Provide input to regulatory inspection responses to ensure systemic, comprehensive solutions address root causes and prevent recurrence.
- Foster a culture that values innovation, continuous improvement, and personal accountability in interactions with direct reports and others.
- Establish and continually improve work standards (including leader standard work) to ensure routine tasks are completed as required and assigned.
- Work across departments and functions to harmonize workflow, identify responsibilities and optimize cross-functional team member participation.
- Mentor, and coach staff to continually develop and enhance skills.
- Lead by demonstrating the company values of standing shoulder to shoulder, owning it always, breakthrough thinking, and competing where it counts.
- Foster a culture of accountability with progressively increased empowerment.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s Degree in Biology, Chemistry, Engineering, or related field
- 10-12 years of cGMP/Quality experience
- Experience in hosting and managing Regulatory Inspections
- Complex analysis of business impacts/scenarios, including risk management, financial analysis (e.g. ROI, Cost of Quality).
- Excellent understanding of Quality Systems requirements
- Strong interpersonal and communication skills
- Strong oral/written and listening skills
- Strong problem-solving skills
- Self-awareness, integrity, judgment, vision, and adaptability are key
- Sound understanding of regulated activities, health authority expectations, and GxP
- Excellent organizational awareness (e.g., research & development, commercial manufacturing, interrelationship of departments, business priorities), including significant experience working cross-functionally and in global, cross- cultural teams.
- Experience developing and executing large-scale organizational change, including change management strategy and planning.
- Proven ability to understand complex processes/problems and facilitate coach teams to optimal solutions
- Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset.
- Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics.