Supplier Quality Manager (SQM)

Intelliswift - An LTTS Company; Novato (CA); Presencial; USD 69 000 - 71 000; Tempo integral

Resumo da oferta

Intelliswift is seeking a Supplier Quality Manager (SQM) on a 12-month contract in Novato, CA. You will own and improve global SQM processes, focusing on SCN and ASL governance, supplier performance, and regulatory compliance for GMP material suppliers across manufacturing sites.

You will collaborate with cross-functional teams including Supply Chain, Compliance, GSP and GMSAT to sustain process health and drive continuous improvement while ensuring adherence to evolving global regulations.

Qualificações

• 6+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry.
• Knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.
• Prior experience in Supplier Quality, Compliance, or related areas; international regulatory landscape preferred.
• Demonstrated ability to work in a matrix environment and drive results through influence.

Responsabilidades

• Lead quality reviews and cross-functional teams as SME for Supplier Change Notifications.
• Manage Client's Approved Supplier List quality governance and health.
• Monitor SCNs via KPIs and trend analysis, driving continuous improvement.
• Present data to management and inspectors; ensure compliance with global health authority requirements.
• Collaborate with Supply Chain, Compliance, GSP, GMSAT and site functions.

Conhecimentos

Biotech industry experience

GMP/GDP knowledge

Supplier Quality

Influence in matrix

Project management

Communication skills

Data presentation

Descrição da oferta de emprego

Job Title: Supplier Quality Manager (SQM)

Duration: 12 Months Contract

Pay Rate: $50 - $51.42/hr

Position Summary:

• Responsible for owning and continuously improving one or more global Supplier Quality Management (SQM) processes at Client. As Business Process Owner (BPO), they are accountable for the overall efficiency/effectiveness of the Supplier Change Notification (SCN) process and Approved Supplier List (ASL) process at Client. The Technical Manager will be accountable for developing, executing associated processes, programs, and initiatives to ensure overall supplier performance for GMP Material Suppliers to support Client's Drug Substance and Drug Product manufacturing. They will contribute to the implementation of a risk-based approach to the management of SCNs and lead efforts for periodic review and updates. They will establish the governance structure and controls to ensure the SCN and ASL processes are consistently applied across the supply base, ensure the health of the SQM process is continuously evaluated, and drive continuous improvement.
• Cross functional collaboration with external and internal partners and stakeholders across different sites and functions is key for success in this role. This includes collaboration with Supply Chain, Compliance, Global Sourcing and Procurement (GSP), Global Manufacturing Sciences and Technology (GMSAT), and other site functions.
• This position requires knowledge and experience with supplier management processes.
• The person must possess technical expertise and business acumen in the areas of responsibility.

Job Duties:

• Lead Quality-related reviews, cross-functional process teams, serving as a subject matter expert for Supplier Change Notifications.
• Lead all quality aspects for the management of Client's Approved Supplier List.
• Establish process to monitor SCNs through key performance indicators (KPIs), trend analysis, and regular reviews, identifying and leading opportunities for improvement.
• Serve as the Business Process Owner for SCN and ASL process(es), proactively monitoring and maintaining the health of the process and subprocesses, driving continuous improvement efforts, and sustaining compliance with current and evolving global health authority requirements and regulations.
• Review and approve Supplier Change Notifications in the QMS.
• Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
• Provide SME support to site inspections, global inspections, and related observation responses.

Knowledge, Skills and Abilities:

• 6+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
• Knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.
• Prior experience and knowledge in Supplier Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. Knowledge in international regulatory landscape preferred.
• Demonstrated ability to work effectively in a matrix environment and drive results through "influence" as well as direct management.
• Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects.
• Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.
• Ability to present data and defend approaches in front of management and inspectors.
• Ability to partner with other functional groups to achieve business objectives.

Equal Employment Opportunity Statement

Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other protected basis under the law.

Americans with Disabilities Act (ADA)

If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department

Other Employment Statements

Intelliswift participates in the E-Verify program.

Learn More

For information on Intelliswift Software, Inc., visit our website at www.intelliswift.com.