Supplier Quality Manager

Company Background:

GenVivo’s vision is to develop revolutionary gene therapies for a healthy and happy world. Our mission is to enable access to innovative treatment options for patients in need of effective medical solutions. Our approach to synergistically attack tumors by activating the immune system - combined with the integration of novel companion diagnostics - positions us on the cutting edge of cancer immunotherapies and emerging clinical-stage cancer companies. We are an ambitious, growing company whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission and values. The company thrives on collaboration and every individual and each idea is important and counts.

General Job Description/Team Overview:

This position is responsible for managing and improving GenVivo’s supplier qualification and monitoring program to ensure service and material suppliers provide the highest quality products and services while also conforming to pre-established requirements. The SQM is also responsible for managing and responding to changes communicated by suppliers and managing raw material specifications. The SQM will be accountable for establishing and driving quality initiatives, improvement opportunities, and ensuring compliance with GxP regulations and company procedures. The level will be determined based upon the candidate’s education, skills, and/or related experience.

Primary Duties and Responsibilities (include but are not limited to):

· Implement and maintain industry best practices associated with the qualification and monitoring of suppliers providing services and materials that affect GXP systems at GenVivo (e.g. manufacturing, packaging, testing, calibration, storage, distribution, etc.).

· Create and manage risk-based processes and programs to qualify GenVivo suppliers.

· Maintain GenVivo’s approved supplier list. Collaborate with internal partners to qualify and on-board new suppliers.

· Review and approve requests for new part numbers and changes to raw material specifications.

· Process vendor change notifications, perform and/or obtain impact evaluations, and alert management of critical supplier issues.

· Develop, review and approve quality agreements with critical suppliers.

· Conduct virtual or onsite supplier qualification audits as necessary.

· Establish and maintain supplier complaint management process.

· Backup for receipt, disposition, and release of raw materials used in or supporting cGMP production.

· Stay current and up to date on any changes that may affect the supply and demand of needed products and materials and advise others of any impact.

· Undertake personal continuous training and development.

· Perform other duties as assigned.

Required Qualifications:

· Bachelor’s degree in a scientific or technical discipline and at least 5 years of Quality experience in regulated pharmaceutical/biotech industry.

· Knowledge of and practical experience in applying cGMPs; experience in administration and/or development of supplier quality systems.

· Experience participating in, managing, and responding to regulatory inspections.

· Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change.

· Ability to work collaboratively, develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.

· Ability to handle multiple simultaneous priorities in a high-volume work environment; ability to manage several tasks simultaneously.

· Sound decision-making, technical and problem-solving skills; demonstrate initiative.

· Innovative, proactive, and resourceful; committed to quality and continuous improvement.

· Good work ethic, dependable, punctual, and flexible; great leader and team player with a can-do attitude.

· Ability to proactively contribute to creating a good team atmosphere.

· Resilient, optimistic and open to change

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

· Excellent organization skills with attention to detail and accurate record keeping.

· General knowledge of Federal and State regulatory requirements in a GxP environment.

· High degree of discretion dealing with confidential information.

· Ability and willingness to work flexible hours when needed.

· Demonstrated ability to work independently and in a team environment.

· Excellent written, verbal, and interpersonal communication skills.

· Eligible to work in the U.S.

Job Type: Full-time

Pay: $110,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Weekend availability

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• San Marino, CA 91108: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

Salary : $110,000 - $130,000