QA Manager

Insync Staffing Inc.; Novato (CA); Hybrid; USD 69,000 - 72,000; Part time

Benefits offered by this job

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

Job summary

Insync Staffing Inc. is seeking a QA Manager to own and continuously improve one or more global Supplier Quality Management processes for GMP material suppliers, supporting drug substance and drug product manufacturing. The role requires cross-functional collaboration across Supply Chain, Compliance, GSP, GMSAT, and site functions.

The position is hybrid, with 3 days in the Novato, CA office. You will implement governance for SCN and ASL processes, monitor KPIs, drive improvements, and support

Qualifications

• 6+ years of experience in 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.
• Demonstrated ability to work effectively in a matrix environment and drive results through influence and management.

Responsibilities

• 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 Approved Supplier List.
• Establish process to monitor SCNs through KPIs, trend analysis, and regular reviews, identifying and leading opportunities for improvement.
• Serve as the Business Process Owner for SCN and ASL processes, maintaining health and driving continuous improvement while ensuring compliance with global requirements.
• Review and approve Supplier Change Notifications in the QMS.
• Collaborate with global and site stakeholders to improve SCN process workflows and align with strategic goals.
• Develop, implement, and communicate quality policies and procedures across the network.
• Support program enhancements to SCN and ASL processes and provide SME support to site/global inspections.

Skills

Supplier Change Notifications

Approved Supplier List

GMP and GDP regulations

Cross-functional collaboration

Project management

Inspection readiness

Education

BA/BS in life sciences or related field

Job description

QA Manager

Hybrid Role - 3 days in the office in Novato, CA

Pay Range: $50.00 - $52.00

Duration: 9 month contract

SUMMARY DESCRIPTION:

Responsible for owning and continuously improving one or more global Supplier Quality Management
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
*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.

RESPONSIBILITIES

• 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 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.
• Make decisions and act with authority to carry out actions as applicable.
• Collaborate with external/internal global and site stakeholders to identify, define, and implement opportunities for improved SCN process workflows, while aligning the process with organizational goals and strategies. Promote knowledge sharing and the best practices.
• Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
• Support implementation of program enhancements to SCN and ASL processes.
• Provide SME support to site inspections, global inspections, and related observation responses.

EDUCATION

• BA/BS in life sciences or related field

EXPERIENCE

• 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 group to achieve business objectives.

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act