PURPOSE AND SCOPE:
Supports FMCNA’s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. The Manager, Pharmaceutical Risk Management provides pharmaceutical risk management expertise across the organization. Pharmaceutical Risk Management is a product lifecycle approach and the Manager will create, develop, implement, and maintain the activities as well as provide Corporate Oversight of the implementation of the Pharmaceutical Risk Management program at all applicable sites. The Manager, Pharmaceutical Risk Management will ensure that all requirements as specified in ICH Q9 are properly administered.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Manages the creation, implementation and execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results for the Pharmaceutical Risk Management program.
- Provides leadership, coaching, to maintain an engaged and productive workforce.
- Interprets company-wide policies and procedures. Involved in the development, modification, and execution of company policies that affect immediate operations with potential company-wide effect. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
- Establishes standard and meaningful objectives and metrics that align to goals, mission, and objectives for applicable department/program. Develops and distributes metrics to support the business.
- Analyzes and reports on trends, and other areas of quality data on a periodic basis.
- Reports on key performance indicators associated with program effectiveness.
- Ensures goals and objectives are aligned between Corporate and sites, including those of the Corporate QMS.
- Interacts frequently with internal departments and external customers/vendors; particularly in problem resolution.
- Remains current with industry standards and best practices to promote activities necessary for the evolution of the Pharmaceutical Risk Management System.
- Ensures procedures are clearly defined and implemented to fulfill regulatory and business requirements. Identifies areas for continuous improvement of these procedures (best in class).
- Ensures documents are properly maintained, with good documentation practices, for all manufacturedand distributed products, quality system processes, and applicable services.
- Keeps up-to-date on new regulations and standards that affect the program.
- Ensures the development and maintenance, as appropriate, of data collection and analysis systems including the development, rationale, and review of process requirements.
- Ensures the establishment of accurate and robust company, site, department, and role-based training requirements/assignments.
- May assist corporate and various sites with the preparation of regulatory responses and periodic updates.
- Provides technical guidance.
- Assists with various projects as assigned.
- Other duties as assigned.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee may be exposed to moving mechanical parts and vibration. Employee may be occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, extreme cold, extreme heat, and risk of electrical shock.
- The noise level in the work environment is usually quiet to loud.
- May occasionally be required to lift and/or move up to 50 pounds.
- Travel 10% - 25%.
May be responsible for the direct supervision of various levels of Risk Management staff.
Bachelor’s Degreerequired,preferably in Science, Engineering, Quality Management, Technical, or Healthcare related field; Advanced Degree desirable.
Professional quality discipline certification (CQE, CQA, CQM or RAB) desired.
Member of PDA, ISPE, ASQ or othertrade Association helpful.
EXPERIENCE AND REQUIRED SKILLS:
Minimum 6 – 8years of related experience in quality systems, preferably risk management in the pharmaceutical industry. Experience in quality assurance, regulatory affairs, compliance preferred.
Strong project management skills.
Ability to generate moderately complex spreadsheets with graphs for trending data and presentations.
Knowledge and application of metrics and charts for quality system processes.
Strong written and verbal communication skills. Ability to communicate effectively with and influence others at different levels of the organization.
Must have a solid understanding of the regulations governing pharmaceutical products.
Knowledge of FDA regulatory requirements (21 CFR Part 820/210/211 and Part 11).
Prior experience with FDA inspections (back office, front office, host) preferred.
Ability to read, analyze, and interpret common scientific and technical journals, financialreports, and legal documents.
Strong technical, business and relations skills directed related to a broad range of compliance areas.
Must be able to interpret regulatory requirements, including FDA activity.
Must be proficient with a personal computer; strong skills with Microsoft Office software.
Experience with database software and design software. Knowledge of Crystal reporting. SAPexperiencedesired.
Understanding of document management, training design principles, curriculum development, adult learning theories, and training effectiveness.
Knowledge of CAPA, Change Control and NC system regulations and standards desired.
Job ID 1800009U