Quality Lead

Job description

Pay: $70k per year plus bonus Location: Garner, NC About Uniphar: Uniphar, founded in 1967, is a leading, global, full-service life sciences and healthcare services company that has grown and expanded its operations internationally across Europe, the USA, MENA and APAC. Working from clinical development to commercialization, our end-to-end services remove barriers to launch, increase access and optimize brands. Capabilities span across consulting, communications, global supply chain, regulatory compliance, medical affairs, medical communications, medical information, field (msl, sales, virtual), access, agency, research, digital, and in-licensing. We have over 3.5K employees, $3 billion in annual revenue, over 200+ multinational partners, and deliver medications to more than 180 countries. Uniphar US operations include integrated services from Uniphar Clinical, Uniphar Logistics, Uniphar Medical, and Uniphar Commercial including Access and Supply chain. We deliver exceptional results driven by trust, innovation, and our patient-first culture. Check out our EVP and why you should work for us: https://uniphar.euwest01.umbraco.io/media/44rfphln/uniphar-pharma_evp_2024_pdf_v2.pdf US Uniphar Website: www.uniphar.us Why Join Us? · Competitive salary: $70k per year plus bonus · Comprehensive benefits: health, dental, vision, 401(k) match, and more · A collaborative, flexible work environment that supports career growth · Opportunity to make a global impact in the dynamic life sciences industry Position Summary: The Quality Lead is responsible for providing day-to-day Quality leadership and compliance oversight for warehouse and distribution activities, with primary responsibility for supervision of the Quality Control (QC) team, commercial import/export Quality activities, DEA-controlled substance inventory oversight, and operational compliance with approved procedures and applicable regulatory requirements. Reporting directly to the US Head of Quality, the Quality Lead serves as the primary Quality presence within warehouse operations and ensures that receipt, storage, handling, picking, packing, shipping, controlled substance activities, and other applicable operational processes are performed in accordance with approved Standard Operating Procedures (SOPs), Good Distribution Practices (GDP), Good Documentation Practices (GDP/GDocP), applicable federal and state regulations, customer requirements, and the company’s Quality Management System (QMS). The Quality Lead is expected to maintain an active presence within warehouse operations, identify and escalate compliance risks, provide immediate Quality guidance when procedural concerns are observed, and work collaboratively with Operations to ensure compliance requirements are integrated into daily execution without compromising Quality independence. Essential Duties and Responsibilities: The primary responsibilities include, but are not limited to the following: 1. QC Team Leadership and Supervision · Provide day-to-day supervision, direction, prioritization, and workload coordination for the QC team. · Assign QC activities based on operational requirements, shipment priorities, risk, and established Quality procedures. · Ensure QC personnel perform inspections, verifications, shipment reviews, documentation reviews, and other assigned Quality activities accurately and within required timelines. · Review the quality and completeness of QC work and address deficiencies, recurring errors, or performance concerns. · Ensure QC personnel are appropriately trained and qualified before independently performing assigned duties. · Support onboarding, coaching, development, and ongoing competency assessment of QC personnel. · Conduct routine team meetings and communicate operational priorities, Quality concerns, procedural changes, and regulatory expectations. · Provide performance feedback to the US Head of Quality and participate in performance evaluations, development planning, and corrective coaching, as applicable. · Monitor QC workload and staffing capacity and escalate resource constraints that could adversely affect compliance or business operations. · Promote consistency, accountability, attention to detail, and a strong Quality culture within the QC function. 2. Warehouse Quality and Operational Compliance Oversight · Maintain a routine and visible Quality presence within warehouse operations. · Observe warehouse activities to verify that personnel perform assigned tasks in accordance with approved SOPs, work instructions, training requirements, customer requirements, and applicable regulations. · Monitor compliance associated with: o Product receipt and inbound inspection o Put-away and inventory movement o Storage and segregation o Temperature-controlled product handling o Picking and order preparation o Packing and shipment preparation o Label and documentation verification o Product release and shipment authorization o Returns o Controlled substance handling o Quarantine and rejected product o Inventory reconciliation o Documentation and recordkeeping · Immediately address or escalate observed departures from approved procedures. · Ensure procedural noncompliance is appropriately documented through the QMS when a deviation, occurrence, investigation, CAPA, or other Quality record is required. · Partner with Operations leadership to identify recurring compliance issues and implement sustainable corrective and preventive actions. · Perform targeted floor audits, process observations, and compliance walkthroughs. · Identify emerging operational Quality risks before they result in product, customer, regulatory, or business impact. · Verify that personnel performing regulated activities are appropriately trained and that required training is current. · Reinforce Good Documentation Practices and data integrity requirements throughout warehouse operations. · Support inspection readiness by ensuring operational practices remain consistent with written procedures and regulatory expectations. 3. DEA and Controlled Substance Inventory Management · Provide Quality oversight for controlled substance inventory management and DEA-regulated distribution activities. · Ensure controlled substances are received, stored, handled, transferred, picked, packed, shipped, returned, reconciled, and otherwise managed in accordance with applicable DEA requirements, state-controlled substance requirements, company procedures, and site security controls. · Perform or oversee routine controlled substance inventory reconciliation activities. · Investigate inventory discrepancies involving controlled substances and immediately escalate unexplained variances to the US Head of Quality. · Review controlled substance transactions for accuracy, completeness, and appropriate documentation. · Ensure required DEA records are complete, accurate, retrievable, and appropriately retained. · Support DEA-required inventories, including initial, biennial, and other inventories as applicable. · Support administration and reconciliation of DEA Form 222 activities, where applicable. · Support ARCOS data collection, reconciliation, review, and reporting activities, as assigned. · Verify DEA registration and applicable state-controlled substance licensing requirements associated with customers, products, and distribution activities. · Ensure controlled substance activities are restricted to appropriately trained and authorized personnel. · Monitor compliance with controlled substance cage/vault access requirements, physical security controls, and inventory segregation requirements. · Support investigations involving controlled substance loss, theft, discrepancies, damage, mis-picks, shipping errors, or suspected diversion. · Immediately escalate suspected theft, significant loss, diversion, unexplained inventory discrepancies, or other potential DEA-reportable events to the US Head of Quality. · Assist with preparation for DEA inspections and