Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionLocation/Division Specific InformationGreenville, NC | Drug Product - North America
How will you make an impact?Manage a professional support staff and contractors responsible for process validation of all products marketed by the company and produced by the company, independent contractors, and international company subsidiaries to include the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes. Negotiate specific process validation criteria and required external resources. Coordinate interdepartmental process validation programs. Represent the department regarding process validation issues during FDA meetings and audits. Identify and resolve validation issues on a timely basis to avoid regulatory action and make recommendations to senior management. Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promoting, disciplining and firing. Identify opportunities and provide the means for employees to pursue career growth.
Essential Functions:- Manages the activities of several functional groups of the Validation Department consisting of supervisory, professional, and technical employees. Manages design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes and computer/information/automation validation.
- Develops, approves, executes, and presents all validation master plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs. Represents the department during audits, meetings, and teleconferences regarding process validation issues with the FDA. Provides responses to FDA deficiency letters and audit observations.
- Manages multi-disciplinary validation teams, approve testing protocol and establish acceptance criteria for validation projects that impact on the production and control of externally produced products, both in clinical supply and trade product manufacturing. Negotiates the scheduling and commitment of specific resources outside the department required for validation projects.
- Audits, evaluates, and qualifies all vendors or contractors. Negotiates validation requirements with these vendors. Plans and establishes technical communications, document flow, testing requirements, and financial resources necessary to produce the validation of the system. Reviews and approves all vendor-supplied documents. Coordinates the audits of inter-departmental validation programs.
- Selects bidders, awards and administers contracts involved for consulting, laboratory, and process validation engineering services. Prepares and defends five-year plans and annual budgets for the department by assessing manpower and capital needs
- Participates in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance as the validation representative on engineering project teams. Develops and maintains a plant wide change control system to review, authorize and document changes to validated systems.
- Provides process validation guidance to domestic contractors and other subsidiaries of the Company supplying US markets regarding current FDA requirements for facility and product approval. Determines FDA's current regulatory and enforcement policies regarding process validation of drug manufacturing for domestic and foreign sites and implement procedures accordingly.
- Represents the Company as an active participant on internal (GQD) and external (ISPE/PDA/PMA) professional committees establishing policy guidelines relating to validation issues.
- Complies with all job-related safety and other training requirements.
- Performs other duties as assigned.
REQUIREMENTS:Education:Bachelor's degree in a scientific, production, or engineering related discipline is highly preferred.
Experience:- 10+ years of validation experience is required, with five to eight years of progressive leadership experience preferred.
- Pharmaceutical or Biotechnical Industry experience should exceed five years.
- Minimum of two years of demonstrated experience in sterilization validation.
- Must have strong project management experience
Equivalency:Equivalent combinations of education, training, and relevant work experience may be considered. 12 to 15+ years of applicable experience may be considered for equivalency to education.
Knowledge, Skills, Abilities:- Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems.
- Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.
- Outstanding attention to detail and organizational skills.
- Self-starter, mature, independent and dependable.
- Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.
- Demonstrated ability to maintain a high degree of confidentiality.
- Effective time management and prioritization skills. Requires discretion and independent judgment.
- Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
- Highly effective verbal and written communication skills.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
