Job Description
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, a Division of Thermo Fisher Scientific - thousands of employees in locations worldwide connected by tenacity and passion.You will be joining a trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.
Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.
As a Director of QA, you will Lead the Vendor Quality Management team by working across functional groups to advise, coordinate, and provide regulatory and quality support through the full vendor lifecycle for sub-contracted vendors, who provide GxP-regulated products and/or services to PPD and PPD clients.
Summarized Purpose:
Provides strategic direction, leadership and management of a QA department and/or program. Where and when role requires incumbent provides oversight to auditing techniques, interpretation of regulations and guidelines, clinical supplies, computer validation and compliance, and/or therapeutic training. Assists business development and senior management in securing new business. Develops effective solutions, using proven problem-solving techniques, to address nonconformance issues with existing clients. Responsible for achieving overall financial goals for department.
Essential Functions:
Prepares the annual vendor audit plan and managing vendor audit escalations
Establishes, tracks, and analyzes vendor quality metrics with select strategic vendors
Ensures the centralization and maintenance of vendor quality data utilizing the Vendor Management System
Works cross-functionally on company-wide vendor management process improvements
Develops, updates, and/or assists with vendor management related procedural documents
Participates in regulatory inspections and client audits and responds to observations, manages audit review responses, facilitates improvements as needed
Participates in business development RFx responses ensuring consistency with vendor management process
Oversees establishment of Quality to Quality programs with external suppliers to align and drive efficient collaboration
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.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Qualifications:
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
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
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
Management Role :
Directs through lower management levels and / or highly skilled specialist employees who exercise significant latitude and independent judgment. Often heads one or more departments or a large, centralized staff function. In some instances, may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.
Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, we d love to hear from you!