Careers

Department: Quality

Reports To: Sr. Director of Quality

Level: Mid-Level to Senior (8+ years of experience)

Location: On Site or Remote - with regular on-site travel required

Travel: 50-60% depending on business needs

The Quality Manager plays a dual role in driving both quality compliance and manufacturing excellence across Colorescience's Contract Development & Manufacturing Organization (CDMO) and supplier network. Reporting to the Quality department, this position serves as a key technical resource and mentor, partnering cross-functionally with Operations, Engineering, R&D, and Supply Chain to ensure that OTC SPF products are consistently manufactured in compliance with FDA OTC regulatory requirements, cGMP standards, Colorescience’s QMS, and internal quality expectations.

This role is equally focused on quality systems and manufacturing process engineering, making it ideal for a well-rounded professional with hands-on CDMO experience in regulated industries such as OTC pharmaceuticals, cosmetics, personal care, or topical products. The successful candidate will bring a proactive, data-driven mindset, strong technical expertise, and the ability to mentor junior team members while independently managing complex quality and manufacturing challenges across outsourced manufacturing sites.

Quality & Compliance

·       Ensure products are manufactured in full compliance with FDA OTC regulations, cGMP requirements, and applicable international standards specific to SPF and topical OTC products.

·       Lead and support CDMO and supplier audits, evaluations, re-evaluations, and ongoing performance monitoring.

·       Work closely with the Sourcing organization on external partners’ performance, including the on-boarding and off-boarding processes.

·       Drive timely and effective closure of CAPAs, nonconformances, deviations, and audit observations.

·       Contribute to Annual Product Reviews and Annual Drug Reviews (ADR), identifying manufacturing and quality trends.

·       Collaborate with CDMOs and suppliers to strengthen process controls, in-process checks, line clearances, equipment setup verification, and manufacturing documentation practices.

·       Proactively identify quality and compliance risks across the CDMO and supplier network and implement preventive actions to minimize product impact.

·       Utilize KPI trending and quality data analytics to identify recurring issues and drive systemic improvements.

·       Promote a proactive quality culture grounded in prevention, continuous improvement, and regulatory accountability.

Manufacturing & Process Engineering

·       Provide technical engineering support for bulk manufacturing, filling, assembly, packaging, process controls, and inspection operations at CDMO sites.

·       Lead and support process optimization initiatives focused on improving efficiency, process capability, right-first-time performance, and reduction of scrap and rework.

·       Collaborate with Operations, CDMOs and suppliers on continuous improvement activities utilizing Lean Manufacturing, Six Sigma, Kaizen, and risk-based problem-solving methodologies.

·       Support engineering trials, validation activities, scale-ups, and pilot runs,.

·       Evaluate manufacturing processes at CDMOs and recommend improvements to strengthen product quality, process consistency, and operational reliability.

·       Analyze manufacturing trends to identify root causes of recurring issues and implement effective corrective and preventive actions.

·       Enforce compliance with FDA regulations and ISO standards internally and within the supply network.

Leadership & Collaboration

·       Serve as a technical mentor and resource for junior Quality and Manufacturing staff, supporting their professional growth and development.

·       Partner closely with Operations, Engineering, R&D, and Supply Chain teams to align on priorities, improvement initiatives, and compliance requirements.

·       Build effective working relationships with CDMOs, acting as a trusted point of contact for quality and manufacturing matters.

·       Ensure quality considerations are integrated into new product launches, technology transfers, and lifecycle management activities.

·       Establish supplier quality governance processes including scorecards, performance reviews, risk assessments, and escalation pathways.

·       Lead business reviews with CDMO leadership teams and strategic suppliers.

·       Drive accountability for quality, compliance, and continuous improvement commitments.

·       Monitor supplier performance and implement corrective actions where necessary.

·       Represent Colorescience’s Quality team in cross-functional project meetings, audits, and supplier and CDMO visits.

·       Support quality risk assessments related to products, processes, suppliers, and manufacturing operations.

·       Recommend mitigation strategies and escalate significant risks appropriately.

·       Balance compliance, quality, operational performance, and business objectives in decision making.

·       Bachelor's degree in Engineering, Chemical Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline preferred.

·       8+ years of experience in Quality Management and Quality Engineering within manufacturing and engineering operations in regulated industry.

·       Experience within OTC pharmaceuticals, cosmetics, SPF/sunscreen products, personal care, topical products, or related regulated manufacturing environments strongly preferred.

·       Direct experience working with CDMOs and supplier networks.

·       Demonstrated experience supporting manufacturing operations, process improvements, validations, investigations, and Quality Management Systems.

·       Strong working knowledge of FDA OTC regulations, cGMP requirements, and risk-based quality management principles.

·       Experience mentoring or providing technical guidance to junior staff is a plus.

·       Strong understanding of Quality Engineering, Manufacturing Operations, Quality Systems, and Regulatory Compliance within OTC and SPF regulated products.

·       Effective in navigating quality compliance activities and hands-on manufacturing processes and engineering challenges.

·       Excellent analytical and problem-solving skills with the ability to identify trends and implement effective corrective and preventive actions.

·       Demonstrated ability to drive quality and manufacturing improvements within outsourced CMO environments.

·       Experience with data analytics and KPI trending to support data-driven decision-making and continuous improvement.

·       Strong leadership presence with the ability to mentor junior staff and influence cross-functional teams and external partners.

·       Excellent communication and collaboration skills; able to build trusted relationships with internal teams and external partners.

·       Familiarity with eQMS platforms, ERP systems, Microsoft Office Suite, and quality data management tools.

·       Self-directed and capable of working remotely and effectively managing their duties and responsibilities in a timely manner

·       Regular travel to external partners’ site is required.

Regular travel is required to CDMOs, suppliers, warehouses, and operational locations. Estimated travel: 50-60% depending on business needs, audit schedules, and project priorities.

The employee may occasionally be required to stand, walk, and perform on-site manufacturing observations, travel to manufacturing facilities and warehouses, and lift and/or move up to 30 pounds. The work environment may include manufacturing operations with varying noise levels and operational activities.