Our leading, global, biotechnology client specializing in regenerative medicine, seeks a “Manager Quality Systems” for their Mountain View, CA location.

The Manager, Quality Systems will be responsible for leading the site Document Management and Change Management systems. The Manager is also responsible for Deviation and CAPA tracking. The Manager will manage the client and regulatory inspection teams and maintain a state of inspection readiness as well as assist in site internal audits and support the supplier audit program. The Manager, Quality Systems is responsible for the review and assurance of compliance to global Quality Standards, Standard Operating Procedures, and relevant GxP regulations and guidelines related to US, EU, and PMDA compliance (or applicable Health Authority Regulations).

• Lead the site Documentation Management program to ensure adherence to global Quality Standards.
• Responsible for the system management of site Change Controls and Deviation and CAPA tracking to ensure adherence to global Quality Standards.
• Manage client and regulatory inspection teams and maintain a state of site inspection readiness.
• Assist in the site Internal Audit Program to ensure compliance to site Standard Operating Procedures and global Quality Standards.
• Participate in Audit Board to assist in evaluating observations, facilitating responses, and developing corrective actions.
• Ensure follow-up on audit observations, tracking of responses, monitoring implementation, and CAPA effectiveness.
• Participate in Supplier Management Program, working with cross-functional site team including preparation and approval of Quality Agreements for site suppliers and vendors and identification of site supplier audit needs and assessment of risks.
• Support the implementation and maintenance of an electronic Quality Management System(e-QMS).
• Develop, track and assist in presenting metrics related to associated site quality systems for Senior Management.
• Participates in continuous improvement initiatives and performs other Quality System duties as assigned.

REQUIREMENTS

• Bachelor's degree in Science or Engineering.
• 5 to 10 years of related experience in a regulated pharmaceutical company required, including experience in Quality, Auditing, and Regulatory.
• Experience with Documentation, Deviation, Change Control systems.
• Experience with regulatory agency inspections with proven ability to lead an inspection team.
• Experience in auditing with auditor certification a plus.
• Knowledge and expertise in principles and practices of GMPs and GCTPs.
• Knowledge of EU, PMDA, and other Health Authority Regulations a plus.
• Experience with writing and approving Standard Operating Procedures and Quality Standards.
• Prior experience with electronic Quality Management Systems (implementation and maintenance a plus).
• Some travel may be required.
• Competencies/Candidate Profile
• Proficient computer skills (Word, Excel, Outlook, PowerPoint, Visio).
• Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers.
• Solid organizational and time management skills, proven project management, presentation and facilitation skills. 
• Innovation and strategic compliance skills including looking internally and externally for best practices.
• The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities.
• The ability to enable and drive change while being focused on internal and external customers.
• Environment includes working with all levels of internal management and staff as well as with external clients and contractors.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.

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