Assoc Director/Director QA - Vaccines, Cell, Gene Therapy at PPD in Richmond, VA
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD -- thousands of employees in locations worldwide connected by tenacity and passion for our purpose:
to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our colleagues in corporate 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 an Associate Director or Director of QA, you will provide strategic direction, leadership, and management of a QA department and/or program. 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. 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:
Develops and executes GxP compliance strategies and establishes quality and compliance standards and matrices for PPD's clinical research operational units Analyzes compliance/quality matrix data, notifies senior management of critical compliance nonconformance Takes leadership role with peers in operational units to proactively identify issues impacting the quality and/or integrity of clinical research and/or laboratory programs, determines root cause of nonconformance, and develops effective problem solution strategies Provide strategic and tactical direction to staff for assigned department(s) inexecution of departmental objectives Hires, develops, and mentors staff to expand organizations capability and ensure effective management of QA staff Manages contracts to ensure contractual obligations and business requirements are met Serves as Senior Advisor to peers, teams, and clients on the interpretation and implementation of current FDA and International GxP and computer validation 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 #LI-AP1 GD Job Qualification Education and
Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10
years-Assoc Dir, 12
years- Director) or equivalent and relevant combination of education, training, & experience. 5
years of management responsibility leading QA teams and strong leadership skills Knowledge, Skills and Abilities:
Knowledge of cell and gene therapies and vaccines preferred Knowledge of GMP and GLP Advanced leadership skills and business acumen Advanced knowledge of financial management and budgeting Strong organizational agility with ability to successfully operate in a matrix or team environment Ability to successfully handle multiple responsibilities, priorities and tasks Exceptional oral and written communication skills Excellent interpersonal skills Successfully applies proven problem-solving skills (e.g., Six Sigma, TQM, etc) Thorough knowledge in interpreting and implementing appropriate FDA regulations 21 CFR and guidelines pertaining to GxP with applicable ICH guidelines, European Directives and country specific regulations on clinical research and drug development Ability to manage complex projects on time and within budget Ability to lead business and process improvement initiatives
Salary Range:
$150K -- $200K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our colleagues in corporate 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 an Associate Director or Director of QA, you will provide strategic direction, leadership, and management of a QA department and/or program. 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. 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:
Develops and executes GxP compliance strategies and establishes quality and compliance standards and matrices for PPD's clinical research operational units Analyzes compliance/quality matrix data, notifies senior management of critical compliance nonconformance Takes leadership role with peers in operational units to proactively identify issues impacting the quality and/or integrity of clinical research and/or laboratory programs, determines root cause of nonconformance, and develops effective problem solution strategies Provide strategic and tactical direction to staff for assigned department(s) inexecution of departmental objectives Hires, develops, and mentors staff to expand organizations capability and ensure effective management of QA staff Manages contracts to ensure contractual obligations and business requirements are met Serves as Senior Advisor to peers, teams, and clients on the interpretation and implementation of current FDA and International GxP and computer validation 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 #LI-AP1 GD Job Qualification Education and
Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10
years-Assoc Dir, 12
years- Director) or equivalent and relevant combination of education, training, & experience. 5
years of management responsibility leading QA teams and strong leadership skills Knowledge, Skills and Abilities:
Knowledge of cell and gene therapies and vaccines preferred Knowledge of GMP and GLP Advanced leadership skills and business acumen Advanced knowledge of financial management and budgeting Strong organizational agility with ability to successfully operate in a matrix or team environment Ability to successfully handle multiple responsibilities, priorities and tasks Exceptional oral and written communication skills Excellent interpersonal skills Successfully applies proven problem-solving skills (e.g., Six Sigma, TQM, etc) Thorough knowledge in interpreting and implementing appropriate FDA regulations 21 CFR and guidelines pertaining to GxP with applicable ICH guidelines, European Directives and country specific regulations on clinical research and drug development Ability to manage complex projects on time and within budget Ability to lead business and process improvement initiatives
Salary Range:
$150K -- $200K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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