Summary: Under administrative direction, develops strategies to ensure Company compliance with internal standards and external regulatory requirements, necessary for the development and delivery of quality NDA/ANDA products in the manufactured at Contract Manufacturing Organizations (CMOs).Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Carries out managerial responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Oversees, directs, coordinates and prioritizes the daily activities of the TP Quality R&D Department.
- Support the supply of Clinical supplies - providing QA checks on labels and protocols, release, distribution/IVRS issues and reconciliation as appropriate.
Ability to provide input to risk assessments when activities change through non GMP to cGMP.
Provide input and approval of product specification files.
Creates, reviews and approves Quality Agreements for development products with CMOs based on corporate QA standards.
Provide Quality review and approval for PD analytical validation activities so that these activities meet the required standards appropriate for the activity and phase of development.
Assists in auditing NDA/ANDA's for pre-approval submissions (in conjunction with the Compliance group).
Collaborate with commercial sites and external operations to ensure technical transfer is handled successfully.
- Remains informed of all national and local legal, regulatory, and governmental regulations relating to Quality R&D. Ensures that the programs are administered in compliance with those policies and regulations. Provide subject matter expertise related to regulations.
- Reviews newly compiled CMC sections of NDA/ANDA's before submission to FDA.
- Provide support PAI FDA or other regulatory agencies inspections by procuring documents, answering questions, etc.
- Oversees, participates and approves the interviewing, hiring, and training of departmental employees; conducts performance evaluations for direct reports; and assists direct report managers with performance evaluation process for their units.
- Provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
- Ensures project deadlines and performance standards are established and met.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations.
- Participates in internal GMP audits of all GMP-related departments within Actavis R&D, reviews findings from audits and writes or reviews reports following each audit, to support R&D QA's Internal Audit program.
Knowledge of: - Extensive knowledge in GxP as applicable to R&D.Understanding of certification requirements for IMP's at all phases of development (Phase I to IV)
- Organizational and interpersonal skills.
- FDA, cGMP and other pertinent standards, guidelines and regulations.
- Principles and practices of budget preparation and administration.Thorough understanding of different manufacturing technologies (Solid-dose, Liquids and Creams, Inhalation, etc.); and analytical laboratory operations.
- Business and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
- Supervision and training practices and methods.
- Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.
- Current Company policies, practices and procedures, including safety rules and regulations.Quality "Risk Assessment" and correction of said risk
- Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
- Responding to inquiries from management, employees and regulatory agencies.
- Preparing, presenting and administering budgets and financial reports.
- Formulating and administering personnel policies, practices and procedures.
- Communicating clearly and concisely, both orally and in writing.
- Managing multiple projects, duties and assignments.
- Interpreting and applying Federal, state and local policies, procedures, laws and regulations.
- The ability to be creative and flexible while maintaining GMP compliance will be critical to the success of this position.
- Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.
- Establishing and maintaining cooperative working relationships with others.
- Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and occasional business travel. Work is performed in an office environment.
Minimum Qualifications: Bachelor's Degree in Chemistry or related field from an accredited college or university, and seven (7) years management level experience, preferably in food, drug or cosmetic industry environment, or an equivalent combination of education and experience