JOB DESCRIPTION:Manager Product Investigations and Shared ServicesAbbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing that provides critical information for the treatment and management of diseases and other health conditions. Our solutions empower clinicians, patients, and communities with timely, reliable insights that drive better health outcomes around the world.
The OpportunityWe are seeking a
Manager Product Investigations and Shared Service join our dynamic Infectious Disease team in
Carlsbad, California. The Manager Product Investigations and Shared Services leads a cross-functional organization responsible for ensuring robust product investigation processes and delivering critical site-wide support services within a biologics manufacturing environment. This role provides strategic and operational leadership across Product Investigations, Environmental Health & Safety (EHS), Facilities & Maintenance, Operational Excellence, and Security to ensure compliance, reliability, and continuous improvement of site operations.
The role is accountable for driving a culture of quality, safety, and operational rigor while enabling efficient, compliant, and uninterrupted manufacturing.
What You'll Work On Product Investigations & Quality Systems- Lead end-to-end product investigation processes, ensuring timely, thorough, and compliant resolution of deviations, non-conformances, and product complaints.
- Ensure root cause analysis is scientifically sound and aligned with regulatory expectations (FDA, EMA, etc.).
- Drive effectiveness of CAPA (Corrective and Preventive Actions) and ensure sustained improvements.
- Partner with Quality, Manufacturing, and Technical Operations to strengthen investigation capabilities and quality culture.
Environmental Health & Safety (EHS)- Provide leadership and oversight for site EHS programs, ensuring compliance with all applicable regulations and corporate standards.
- Promote a proactive safety culture focused on risk identification, mitigation, and continuous improvement.
- Oversee incident investigations and ensure appropriate corrective actions are implemented.
Facilities & Maintenance- Ensure reliable operation and maintenance of GMP and non-GMP facilities, utilities, and equipment.
- Oversee preventive and predictive maintenance programs to minimize downtime and maintain compliance.
- Support capacity, capital projects, and operational readiness as needed.
Operational Excellence- Lead continuous improvement initiatives leveraging Lean, Six Sigma, and other operational excellence methodologies to reduce waste.
- Drive achievement of the site gross margin improvement target.
- Establish and monitor KPIs across the organization to ensure operational performance and accountability.
Security- Oversee site security operations to ensure the safety of personnel, assets, and intellectual property.
- Ensure effective access control, incident management, and regulatory compliance related to site security.
Leadership & Cross-Functional Collaboration- Build, lead, and develop a high-performing, multidisciplinary team.
- Foster strong collaboration with Quality, Manufacturing, Supply Chain, Engineering, and corporate functions.
- Serve as a key member of the site leadership team, contributing to strategic planning and decision-making.
- Champion a culture of accountability, transparency, and continuous improvement.
Required Qualifications - Bachelor's degree in engineering or in life sciences or business.
- 8-12 year's experience in biologics, pharmaceuticals, or regulated manufacturing environments
- Demonstrated leadership experience managing diverse functional areas (e.g., investigations, EHS, facilities, or operations).
- Results-oriented with a strong focus on compliance, safety, and operational excellence.
- Proven experience in deviation management, root cause analysis, and CAPA systems with strong problem-solving skills.
- Knowledge of EHS regulations and best practices.
- Familiarity with facilities management, maintenance systems (CMMS), and utility operations.
- Excellent communication and stakeholder management capabilities.
- Requires frequent cross-functional engagement and on-floor presence.
- Experience providing support during audits, inspections, or critical operational events.
Preferred Qualifications- Experience with Lean/Six Sigma or other continuous improvement frameworks preferred.
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Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
The base pay for this position is $130,700.00 - $261,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Engineering
DIVISION:ID Infectious Disease
LOCATION:United States > Carlsbad : 2251 Faraday Ave
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 20 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Wear ear plugs, Work in a clean room environment, Work in noisy environment