Sr. Quality Assurance Director
Boca Raton, FL
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Sr. Quality Assurance Director
- Location: Boca Raton, FL (position is on-site, not remote)
- Industry: Biologics
- Hours: M-F, 8am-5pm
- Employment Type: Direct hire
- Salary: Competitive compensation package plus bonus incentives
Leading commercial biopharmaceutical company committed to manufacturing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection.
Lead the department to ensure compliant Quality Management Systems and auditing programs are established and maintained in conformity with applicable company and US/worldwide regulatory requirements, standards, guidance and procedures for the development of drugs and biologics. Manage, direct, oversee and continuously improve Quality Management Systems including Deviations, CAPAs, Change Controls, and internal/external auditing. Experienced in hands on projects using Lean Six Sigma (LSS) and risk management processes to improve product quality and process efficiency and efficacy.
- Develop and lead the strategy, implementation and leadership of the Quality organization and is accountable for the continuous development, execution and administration of a comprehensive GxP Quality System meeting all compliance requirements pertaining to Good Manufacturing Practices (GMP), ICH, FDA, EMA regulations.
- Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
- Establish and maintain phase appropriate GMP compliance for product manufacturing, testing, and stability; ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
- Quality management of CMOs, contract test laboratories and other vendor services to ensure compliance with manufacturing and testing of company products. Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.
- Provide operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints.
- Experience in leading regulatory audits and interfacing with regulatory agencies primarily the FDA in either CBER or CDER.
- Education Requirements: Bachelor s/Master s degree in science or related technical field.
- Experience Requirements: Minimum of 15 years experience in the biologics pharmaceutical industry (CBER Regulated); 5-10 years experience in quality management.
- Minimum of 5 years as a Team/Department Leader with proven success in coaching, mentoring and improving the overall team performance as determined by standard metrics.
- Must have demonstrated experience in managing a quality management program in a biological pharmaceutical environment. Knowledge in and experience in the blood products industry preferred. High degree of FDA regulation and cGMP experience.
- Promotes a culture of quality and operational excellence and ensure the Quality Systems support the strategic plan to advance the company's Mission, Vision and Principles.
- Manages and is responsible for the Quality Assurance department which includes managing the staff by providing guidance, training, coaching and strategic leadership. Manage and develop talent that provides overall Quality oversight. Overall department up to 25 team members.
- Oversees tracking and trending of quality systems and presents information/reports to senior level management regarding the status.
- Confirms all Quality Systems are in compliance with cGMPs. Trending and reporting all Quality KPI s on a periodic basis.
- Responsible for all product releases for commercial distribution. Ensures all controlled documents and records meet cGMP requirements.
- Develops processes and guidelines for quality system management and oversees continuous improvements to ensure enhanced compliance to cGMPs and evolving FDA expectations.
- Provides cGMP guidance to internal departments for all phases of product development, as applicable. Participates and represents QA in development project team meetings and discussions.
- Accountable for the Quality Assurance budget adherence including identification of staffing requirements.
- Ensures that the internal and external audit programs are appropriate and robust to identify existing or evolving non-compliances.
- Overall responsibility for the management of FDA audits and inspection responses and projects within quality.
- Exceptional verbal and written communication skills.
- Demonstrated ability for analytical and systematic thinking. Proficient in risk assessment and root cause analysis tools. Ability to use LSS tools and methodology to implement compliant, simplified processes to ensure enhanced compliance to cGMPs and evolving FDA expectations.
- Ability to manage budget and resourcing and to lead a department.