Position/Title: Director, Quality Systems
- Function:
Oversees the development, implementation and maintenance of quality assurance and control systems and activities. Oversees generation and review of documents used in Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP). Monitors audits of production and Quality Control (QC) areas. May audit raw material vendors and prepares manufacturing documentation for updated filing. Coordinates interdepartmental activities. May lead investigations and resolve potential product quality issues to improve efficiency. - Specific Responsibilities and Activities:
- Develops, establishes and maintains the Quality Assurance (QA) programs, policies, and procedures to ensure cGMP compliance of clinical trial material, cGLP compliance of pre-clinical studies and cGCP compliance of clinical trials.
- Act as the primary QA and QC contact with vendors, contract facilities and joint development collaborators for contracts, validation, change management and other Quality issues.
- Oversees and manages the auditing process and all other QA inspectional activities.
- Ensures company's compliance with Title 21 CFR (Code of Federal Regulations) Part 11 for document management and publishing software.
- Oversees the administration of the company's SOP system and cGXP training program.
- Understands regulatory agency policies and guidance as it pertains to Quality issues.
- Manages the QA review of manufacturing records, clinical trial documentation and documents submitted to regulatory agencies.
- Assist in monitoring current and proposed quality, scientific and pertinent legal issues and advise management on events of significance for the company's business interests.
- Supervisory Responsibilities:
- Directly supervises employee(s)
- Education/Experience/Skills:
Education:
- BS/BA degree in related discipline and eleven years of related experience; or,
- MS/MA degree in related discipline and nine years of related experience; or,
- May require certification in assigned area.
- Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.
- Experience in Biotech/Pharmaceutical industry preferred.
- Minimum eight years pharmaceutical industry and/or regulatory agency experience with at least 5 years quality assurance experience in a position of substantial responsibility.
- Working knowledge of drug development process and the Federal laws and regulations affecting the pharmaceutical industry.
- Has extensive experience in relevant industry/profession.
- Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
- Develops technical and/or business solutions to complex problems.
- Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
- Guides the successful completion of major programs, projects and/or functions.
- Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
- Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
- Has complete understanding and wide application of technical principles, theories, concepts and techniques.
- Has extensive knowledge of other related disciplines.
- Applies strong analytical and business communication skills.
- Job Complexity:
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
- If in a leadership role, works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
- Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
- If in a leadership role, participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
- Ensures budgets and schedules meet corporate requirements.
- Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
- Disclaimer:
- The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
For immediate consideration send resume or CV to:
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