Quality & Compliance Lead
About the role
The Quality & Compliance Lead establishes and maintains a robust, fit-for-purpose quality management system to support the development, launch, and commercialization of agricultural products manufactured through external partners.
Responsibilities
- Develop and maintain a comprehensive Quality Management System (QMS) tailored to a virtual and outsourced manufacturing environment.
- Establish clear quality standards, specifications, and release requirements for products manufactured by contract manufacturing organizations (CMOs) and tolling partners.
- Qualify, onboard, and periodically assess contract manufacturers, formulators, packagers, and critical suppliers to ensure they meet quality and compliance expectations.
- Define, implement, and maintain supplier quality agreements, including performance expectations and roles and responsibilities.
- Monitor manufacturing performance using key performance indicators, scorecards, and regular business reviews, and address gaps proactively.
- Support technology transfer, scale-up, validation, and commercial launch activities for new and existing products.
- Ensure products and manufacturing operations comply with applicable regulatory requirements, customer specifications, and internal company standards.
- Maintain a state of audit readiness and coordinate supplier audits, qualification assessments, and compliance reviews.
- Lead investigations related to deviations, customer complaints, out-of-specification results, and non-conformances, ensuring thorough root cause analysis.
- Drive corrective and preventive actions (CAPA), verify the effectiveness of implemented actions, and embed lessons learned into procedures and practices.
- Oversee change control processes to assess and manage impacts on product quality, regulatory compliance, and supply continuity.
- Identify, assess, and mitigate quality and compliance risks across the external manufacturing network using structured risk assessment and mitigation approaches.
- Partner with Regulatory, Product Development, Supply Chain, and Commercial teams to support successful product introductions and lifecycle management.
- Establish quality requirements for new products and ensure manufacturing readiness and robust controls are in place prior to launch.
- Participate in process optimization initiatives to improve product consistency, manufacturability, and cost competitiveness.
- Support inventory disposition decisions and product release processes, ensuring timely and compliant supply to customers.
- Develop and execute supplier improvement plans and collaborate with manufacturing partners to enhance quality, reliability, and service.
- Analyze quality trends, identify systemic issues, and implement preventive measures to reduce risk, variability, and defects.
- Promote and reinforce a culture of quality across the organization and the external partner network through communication, training, and example.
- Build strong partnerships with external manufacturers and suppliers, driving accountability and continuous improvement across the manufacturing network.
Essential Skills
- Bachelor's degree in Agriculture, Chemistry, Engineering, Biology, Pharmacy, or a related discipline.
- 8+ years of experience in Quality Assurance, Compliance, Manufacturing, or Supplier Quality within agriculture, biologicals, crop protection, biotechnology, or specialty chemicals.
- Proven experience managing quality systems in outsourced or virtual manufacturing environments.
- Demonstrated experience working with CMOs, toll manufacturers, formulators, and global supply partners.
- Hands-on experience with supplier qualification, audits, quality agreements, CAPA, change management, and product launch processes.
- Strong understanding of quality assurance principles, industry compliance requirements, and process-oriented quality systems.
- Experience creating, implementing, and maintaining standard operating procedures (SOPs), particularly for toll manufacturers and new CMOs.
- Proficiency in CAPA and root cause analysis methodologies, with the ability to drive effective corrective and preventive actions.
- Capability to apply structured risk assessment and mitigation techniques to quality and compliance risks.
- Strong communication, influence, and relationship management skills, including the ability to influence without direct authority.
- Able to operate effectively in a fast-paced, resource-constrained startup environment with shifting priorities.
- Demonstrated agility and execution focus, with a track record of driving continuous improvement and cross-functional collaboration.
Additional Skills & Qualifications
- Advanced degree in a relevant scientific or engineering discipline is preferred.
- Experience in agriculture, biologicals, crop protection, biotechnology, or specialty chemicals with exposure to active ingredients and manufacturing processes.
- Familiarity with six sigma or other continuous improvement methodologies.
- Experience working more with manufacturing sites than laboratory environments, including support for selection and qualification of toll manufacturers.
- Ability to develop and refine SOPs and quality processes for new and existing CMOs and tolling partners.
- Strong discipline and process orientation, with a focus on implementing, following, and continuously improving quality systems.
- Experience promoting a culture of quality and accountability across internal teams and external partners.
- Forward-thinking mindset with strong planning and strategic thinking abilities, including comfort with evolving priorities.
Work Environment
This role operates in a dynamic, fast-paced startup environment that relies heavily on external manufacturing partners across multiple regions. The position focuses more on collaboration with manufacturing sites and external CMOs and toll manufacturers than on laboratory-based work. Priorities may shift as the organization grows and plans for the near future, so the successful candidate will demonstrate flexibility, adaptability, and comfort with evolving job functions.
Job Type & Location
This is a Contract to Hire position based out of Santa Monica, CA.
Pay And Benefits
The pay range for this position is $57.60 - $63.00/hr.
Requirements
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
San Francisco Fair Chance Ordinance
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector
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