Position and Landos Statement
The Quality Systems Manager is a highly motivated individual, self-started with an A+ attitude and proven ability to follow through who will be involved in managing agile/lean operations. The position will manage a number of tasks and projects simultaneously. This position will be responsible for performing diverse responsibilities requiring sound judgment, problem solving skills and a working knowledge of all GXP quality systems.
Landos is a clinical stage biotech and the candidate will be completely aligned with three fundamental pillars of Landos’ corporate culture: 1) Be bold and decisive, 2) Never give up, and 3) Do the impossible.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to the following
- Develop, implement, manage, audit and maintain GXP quality systems to support developmental and commercial activities for a pharmaceutical company.
- Provide leadership to and manage the daily activities of the QA Systems and Compliance.
- Demonstrate leadership by ensuring the continuous improvement of the Quality Management Systems at CMOs, contract test labs and clinical sites.
- Ensure management of changes associated with products and processes are carried out appropriately using scientific and risk-based assessments to assess the impact of change.
- Manage the Internal and External Audit programs to ensure Suppliers are in compliance with applicable regulations. Coordinate and perform all vendor qualification and compliance audits.
- Coordinate activities and support interactions during regulatory agency inspections and customer audits. Work across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
- Develop, manage and maintain a GXP compliant document control system.
- Ensure key performance indicators measure progress against quality objectives.
- Monitor, communicate and act on any emerging regulatory and compliance trends.
- Be a Subject matter Expert for interpreting regulations and applying them to compliance situations as applicable for Phase 1 to 3 drug development programs and or commercial drug manufacturing, testing, packaging and distribution.
- Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
- Represent QA at senior management, project, Board, and review meetings.
- Minimum BA/BS in life sciences (Biology, Chemistry), Advanced degree preferred.
- A minimum of ten (10) years of experience in the pharmaceutical or biopharmaceutical industry with increasing levels of responsibility. A minimum of five (5) years relevant experience in a Quality leadership function (QC or QA) is also required.
- Experience establishing and managing Quality Systems or Supplier Quality is preferred.
- Hands on experience in writing SOPs
- Demonstrated ability in problem solving, strong understanding of cGMP and GxP.
- Excellent understanding of Quality principles, industry practices, and standards with demonstrated ability to apply these to GMP operations at CMOs and Suppliers.
- Independent decision making with a high degree of initiative.
- Extensive knowledge of US Drug Product and API GMP requirements and guidelines.
- Hands on experience implementing quality systems in a GXP environment, and direct experience with FDA and other health authority inspections.
- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
- Significant hands on experience in a biopharmaceutical company, including clinical and commercial products.
- Experience in participating in pharmaceutical technology transfer teams.
- Experience in the qualification of facilities, utilities, equipment and processes.
- Demonstrated experience and leadership in GxP compliance audits.
- Excellent verbal and written communication skills, including the ability to lead complex projects.
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Flexible schedule
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