Quality Lead

Quality Lead## Quality LeadApply: North Carolina: Full time: Posted Today: JR-0000008893Pay: $70k per year plus bonusLocation: 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: **US Uniphar Website:** ** **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 inspectiono Put-away and inventory movemento Storage and segregationo Temperature-controlled product handlingo Picking and order preparationo Packing and shipment preparationo Label and documentation verificationo Product release and shipment authorizationo Returnso Controlled substance handlingo Quarantine and rejected producto Inventory reconciliationo 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 participate in regulatory inspections as requested.· Maintain inspection-ready controlled substance documentation and inventory records.4. Quality Management System Responsibilities· Ensure activities within the Quality Lead’s area of responsibility comply with the established QMS.· Initiate, investigate, review, or support deviations, occurrences, nonconformances, CAPAs, change controls, complaints, and other Quality records, as assigned.· Perform root cause analysis and facilitate development of appropriate corrective and preventive actions.· Monitor assigned CAPAs and Quality actions through timely closure.· Identify recurring issues and recommend systemic improvements.· Support creation and revision of SOPs, work instructions, forms, and controlled records.· Ensure revised procedures are effectively implemented within warehouse operations.· Participate in Quality risk assessments and operational risk evaluations.· Support internal audits, customer audits, supplier audits, and regulatory inspections.· Ensure audit and inspection observations assigned to the function are addressed within established timelines.· Support effectiveness checks to confirm implemented corrective actions remain sustainable.· Escalate significant Quality, regulatory, product, or patient-safety concerns to the US Head of Quality.5. Training and Compliance· Reinforce employee understanding of SOPs, regulatory requirements, GDP/GDocP requirements, controlled substance requirements, and Quality expectations.· Identify training gaps through floor observations, investigations, QC findings, audits, and trending.· Coordinate with functional management to ensure required retraining is completed when deficiencies are identified.· Provide or facilitate Quality-related training within areas of demonstrated competency.· Verify personnel understand not only procedural steps but the compliance rationale behind critical controls.· Promote a culture in which employees appropriately escalate errors, discrepancies, and potential compliance concerns.6. Metrics, Trending, and Continuous Improvement· Track and trend Quality and operational compliance indicators, including, as applicable:o QC errorso Documentation errorso Shipment errorso Inventory discrepancieso Controlled substance discrepancieso Export documentation errorso SOP noncomplianceo Deviations and occurrenceso Repeat observationso Training deficiencieso CAPA completion· Identify adverse trends and escalate significant or recurring issues to the US Head of Quality.· Develop recommendations to improve compliance, efficiency, right-first-time performance, and inspection readiness.· Provide Quality metrics and operational compliance updates for management review and leadership reporting.· Participate in continuous improvement initiatives while ensuring proposed efficiencies do not compromise regulatory or Quality requirements. **Quality Authority**The Quality Lead is authorized to:· Intervene when an activity is being performed contrary to an approved SOP, regulatory requirement, Quality requirement, or established product requirement.· Place product, inventory, documentation, or shipment activities on Quality Hold when a potential compliance or product-quality concern exists.· Require correction of documentation or procedural deficiencies prior to Quality approval.· Require escalation and investigation of suspected deviations or regulatory noncompliance.· Prevent the release or shipment of product when required Quality, regulatory, licensing, controlled substance, or documentation requirements have not been satisfied.· Escalate significant compliance concerns directly the US Head of Quality.· Recommend retraining, procedural changes, CAPAs, process improvements, and additional controls based on identified Quality risks.Final authority for significant Quality-system decisions, regulatory reporting, regulatory agency communications, and other matters reserved to senior Quality leadership remains with the US Head of Quality or designated senior Quality representative, unless formally delegated. **Basic Minimum Qualifications ·**Seven (7)+ years in a regulated life-sciences role · Experience with cGMP, and recordkeeping related to controlled substances. · Proven experience with FDA 21 CFR Part 11 systems including validation and audit trails · Experience with ISO 134865:2016 **Education/Experience: ·**Bachelors degree or work experience related to the position. **Ability and/or Skills: ·**Comprehensive understanding of FDA and DEA regulatory requirements, including GMP/21 CFR compliance and federal, state, and local controlled substance regulations.Excellent recordkeeping skills, with a high level of attention to detail. · Expertise in accurate, compliant documentation and recordkeeping, ensuring all controlled substance and GMP-related records meet regulatory and audit standards.· Strong risk management and decision making; corrective and preventive actions (CAPA).· Highly self-directed with strong organizational and time‐management skills, ensuring timely completion of compliance‐critical tasks in a regulated environment.· Skilled in communicating regulatory expectations across cross‐functional teams, including delivering training on FDA, DEA, and controlled substance handling requirements.· Proficient in controlled substance inventory control systems and electronic recordkeeping tools, as well as standard Microsoft applications (Outlook, Teams, Excel, etc.) to support compliance activities **Physical Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to walk, sit and use hands for grasping, pushing, pulling and fine manipulation.. Physical duty: Medium.. Must be able to lift 10 pounds frequently and 25 - 50 pounds occasionally. Occasionally will drive a forklift. Must be able to occasionally bend, squat, crawl climb and reach above shoulder level. Will be exposed to loud noises including production and manufacturing machinery. **Equal Opportunity Employer**We recognize the right of an individual to work and to advance on the basis of merit, ability, and potential. It is our to ensure that job applicants are considered, and that employees are treated during employment, without regard to their race, color, religion, creed, sex, national origin, age, physical or mental disability, veteran status or Vietnam-Era veteran status, citizenship, marital status, domestic partnership status, familial status, gender identity, sexual orientation, legally protected medical condition (including pregnancy, childbirth, or related medical condition), genetic characteristics or other characteristic, condition or classification protected by federal, state, or local law. Uniphar is committed to the principles of equal opportunity and resolves to ensure equal opportunity in all employment practices. Join us in shaping the future of healthcare solutions by leading innovative medical strategies that make a meaningful difference in patient outcomes worldwide! #J-18808-Ljbffr