- Coaches and mentors the Quality Assurance (QA) staff regarding some, or all, of the following activities:
- Compliance, auditing techniques, interpretation of regulations and guidelines, clinical supplies, laboratory QA services.
- Assists business development and senior management in securing new business by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences.
- Develops effective solutions, using proven problem-solving techniques, to address nonconformance issues with existing clients.
- Coordinates client and regulatory audits and inspections.
- Recruits and identifies qualified quality personnel.
- Provides regulatory support for clients such as coordinating validation and agency questions.
- Coordinates site compliance and regulatory efforts for multiple business units to assure seamless client interface.
- Develops and executes compliance strategies and establishes quality and compliance standards and matrices for operations within and across GQC business units
- Assures that all quality systems are in place and appropriate to meet business area client and regulatory expectations. Analyzes compliance/quality matrix data, notifies executive leadership of critical compliance nonconformance
- Takes leadership role with peers to proactively identify issues impacting the quality and/or integrity of clinical and/or laboratory programs, determines root cause of nonconformance, and develops in collaboration with teams effective problem solution strategies
- Directs assigned department in execution of departmental objectives. Hires, develops, and mentors staff to expand organizations capability and ensures effective management of staff
- Manages contracts to ensure contractual obligations and business requirements are met
- Advises peers, teams, and clients on the interpretation and implementation of regulatory agency trends and requirements
- Assesses impact of client and regulatory observations of data integrity and overall quality management and provides recommendation for corrective action to the respective teams
- Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences
- Fosters client relationships and provides strategic guidance on quality business initiatives. Provides regulatory support for clients as needed for addressing regulatory concerns such as validation issues and agency questions as needed
- Maintains leadership role through active participation in leadership team meetings, presentations to site staff on compliance and quality issues
- Develops and maintains applicable quality and site metrics. Participates on site quality and business process improvement issues
- Handles delegated tasks and responsibility as requested by senior leadership.
- Represents QA at client audits and regulatory authority inspections
- Maintains expertise with international regulatory requirements by attending external training programs, maintaining current reference library and attending
- FDA sponsored public conferences
Education and Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years) or equivalent and relevant combination of education, training, & experience.
- 5 years of management responsibility
- Proven leadership skills
Knowledge, Skills and Abilities:
- Excellent leadership skills and business acumen
- Advanced knowledge of financial management and budgeting
- Ability to successfully operate in a matrix or team environment
- Ability to handle multiple responsibilities, priorities and tasks
- Excellent verbal and written communication skills including appropriate use of medical and scientific terminology
- Demonstrated proficiency with regulations and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures
- Ability to apply proven problem-solving skills
- Ability to apply business and process improvement methodologies
- Ability to manage complex projects on time and within budget