Senior quality compliance manager responsible for assuring the Company is compliant with CLIA, GCP, GLP, OSHA, and other regulations.
Duties and Responsibilities
- Oversee Quality Management System in place at the Company
- Responsible for approving Standard Operating Procedures (SOP) for regulated activities of the Company.
- Investigating and preparing Unexpected Events reports for top management.
- Review and sign-off approval of all project final reports
- Responsible for short and long-term goals of quality control (QC) laboratory efforts in support of client’s project goals including IND filings
- Formulates and recommends quality assurance (QA) policies and programs.
- Develops departmental budget for quality assurance and quality control, including defining materials, equipment, and personnel needs.
- Directs QA/QC staff and daily operations to include release testing, in- process testing, inspections and audits, documentation, equipment maintenance and calibration and laboratory design and maintenance.
- Manages audits with biopharma auditors and state inspectors
- Manages GCP material control program to include materials management including labeling and storage, materials inventory, use, and materials lot control.
- Oversees component and finished product stability program, transfer of validated methods to routine use, and participation of staff in support of validation of methods and equipment.
- Establishes and directs control programs and training programs.
- Review and approves reports and other documentation prepared by QA and QC for regulatory submissions/inspections.Assures finished data conform to government and company standards and satisfies GCP and CLIA regulations.
- Enforces Health and Safety policies with personnel
- Education – M.S. in Biology, Chemistry, Biochemistry, or similar field.
- Specialized knowledge – Certification or strong experience in GCP and general quality systems such as ISO 9000 series.
- Skills – Good organizational, management and people skills. Good computer skills with mid to advanced level in MS Office products (Word, Excel, PowerPoint) and Adobe.
- Abilities – must be able to communicate effectively with scientists, lab personnel, Project Managers and Company management.
- Professional Certification – Quality Assurance, preferred.
- Experience – Three to five years experience in GCP laboratories including two years of management and three years in pharma or biotech companies.
Job requires possible long hours to meet goals of the company.
Although not physically demanding, reasonably good health is required for this demanding position.
Please email your resume to firstname.lastname@example.org and reference QA0008 in the subject line.