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Key Responsibilities and Required Skills for Quality Control Program Manager

💰 $95,000 - $150,000

QualityOperationsManufacturingRegulatory

🎯 Role Definition

The Quality Control Program Manager leads the design, implementation, and continuous improvement of the Quality Control (QC) program across manufacturing and laboratory operations. This role defines QC strategy, develops inspection/test protocols, ensures regulatory and customer compliance (ISO, GMP, FDA), drives CAPA and root-cause programs, manages cross-functional quality initiatives, and delivers measurable KPIs that reduce defects and increase first-pass yield. The manager partners with Production, R&D, Supply Chain, and Supplier Quality to embed risk-based controls, statistical process control, and data-driven decision making into daily operations.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Senior Quality Engineer with hands-on inspection, test, and control plan ownership
  • Supplier Quality Engineer or Manufacturing Process Engineer with QC exposure
  • Quality Assurance Specialist with audit and CAPA responsibility

Advancement To:

  • Director of Quality Operations
  • Head of Quality Assurance / Quality Control
  • VP of Global Quality & Compliance

Lateral Moves:

  • Supplier Quality Manager
  • Regulatory Affairs Manager
  • Continuous Improvement / Operational Excellence Lead

Core Responsibilities

Primary Functions

  • Develop, implement, and maintain the enterprise QC program and related Standard Operating Procedures (SOPs), inspection instructions, sampling plans, and acceptance criteria to ensure product conformity and regulatory compliance.
  • Lead end-to-end QC strategy for incoming, in-process, and finished-goods inspection including risk-based sampling, lot release controls, and environmental monitoring to meet ISO, GMP, and customer requirements.
  • Own and continuously improve the Quality Control Management System (QMS) elements related to testing, nonconformance handling, and lab controls, ensuring full traceability and audit readiness.
  • Design and execute statistically sound sampling plans and statistical process control (SPC) methodologies to detect process drift early and reduce variability in critical-to-quality attributes.
  • Establish, track, and report KPIs and quality metrics (e.g., defect per million opportunities, first-pass yield, out-of-spec rates, CAPA closure time) and present actionable insights to senior leadership to drive quality improvement projects.
  • Lead cross-functional investigations and root cause analyses (8D, RCA, Fishbone) for critical failures and systematically drive CAPA implementation, verification, and effectiveness checks.
  • Manage QC laboratory operations including test method development, validation, equipment calibration, measurement systems analysis (MSA), and lab accreditation activities to ensure data integrity and reproducibility.
  • Author and approve lot release criteria, quality certificates, and product disposition decisions; coordinate final release with QA and Regulatory as required.
  • Direct supplier quality control activities, including supplier qualification, incoming inspection strategies, supplier audits, nonconformance management, and supplier-led CAPAs to protect the supply chain.
  • Oversee training programs for QC inspectors and technicians; develop competency matrices, perform assessments, and ensure proficiency in test methods and inspection techniques.
  • Partner with Manufacturing and Engineering to incorporate quality gates into production flows, optimize inspection points, reduce rework, and support first-time right initiatives.
  • Drive continuous improvement programs (Lean, Six Sigma) focused on defect elimination, cycle time reduction, and cost of poor quality (COPQ) reduction across product lines and sites.
  • Lead regulatory and customer audits for QC scope, respond to audit findings, implement corrective plans, and manage long-term compliance commitments.
  • Implement digital quality tools and automation (LIMS, QMS, MES integrations) that improve sample tracking, test scheduling, data capture, and real-time quality dashboards.
  • Define and manage QC budgets, capital requests for lab equipment, and resource planning to scale QC capabilities in line with business growth.
  • Coordinate cross-site harmonization of QC methods and specifications to ensure consistent product release standards across domestic and global manufacturing locations.
  • Simplify and standardize documentation practices for work instructions, test reports, deviation records, and control plans to reduce errors and accelerate release timelines.
  • Lead product / process validation and qualification activities (IQ/OQ/PQ) for new product introductions and major process changes to ensure robust quality performance at launch.
  • Interface with Regulatory Affairs to ensure QC processes capture required data for filings, change controls, and post-market surveillance reporting.
  • Use advanced analytics and root-cause modeling to prioritize quality improvement investments and to quantify the business impact of QC initiatives.
  • Provide leadership during quality incidents, recalls, or field actions: coordinate containment, communication, investigation, and remediation with cross-functional crisis teams.
  • Mentor and develop QC team members, build bench strength, and establish succession planning to maintain operational resilience.

Secondary Functions

  • Support tactical investigations and ad-hoc lab testing requests from R&D and Manufacturing, ensuring timely prioritization and documentation of results.
  • Maintain and contribute to the organization’s quality data strategy, enabling ML-ready data structures for anomaly detection and predictive quality.
  • Collaborate with cross-functional product teams to translate quality requirements into engineering specifications, inspection checkpoints, and test methods.
  • Participate in sprint planning and Agile ceremonies for continuous improvement initiatives when interacting with software, automation, and digital quality teams.
  • Facilitate periodic risk assessments (FMEA, HACCP where applicable) and ensure risk mitigations are reflected in inspection and test plans.
  • Support supplier development projects including capability assessments, measurement system improvements, and on-site training to elevate supplier performance.

Required Skills & Competencies

Hard Skills (Technical)

  • Quality Management Systems (QMS) design and administration — demonstrated experience with ISO 9001, ISO 13485, and/or GMP frameworks.
  • Regulatory compliance and audit readiness — preparing for and responding to FDA, notified body, and major-customer audits.
  • Root cause analysis methodologies — 8D, Pareto, 5 Whys, Fault Tree Analysis with proven CAPA closure track record.
  • Statistical Process Control (SPC), measurement systems analysis (MSA), and design of experiments (DOE).
  • Sampling plan design, AQL concepts, and acceptance criteria development for incoming and in-process inspection.
  • Test method development, method validation, and laboratory management (LIMS experience preferred).
  • Failure Mode and Effects Analysis (FMEA) for product and process risk assessment.
  • Quality data analytics — Excel, Minitab, JMP, Python/R familiarity for trend analysis and predictive quality modeling.
  • ERP and QMS tools — experience with SAP QM, Oracle, MasterControl, TrackWise, or equivalent systems.
  • Supplier quality management — supplier audits, PPAP, supplier corrective action, and performance metrics.
  • Process validation and equipment qualification (IQ/OQ/PQ) in regulated environments.
  • Lean and Six Sigma methodologies — Yellow/Green/Black belt experience preferred for leading improvement projects.
  • Documentation control and technical writing — SOPs, work instructions, validation protocols, test reports.
  • Environmental monitoring and contamination control where applicable (pharma/biologics/device contexts).
  • Product release protocols and lot disposition decision-making.

Soft Skills

  • Strategic leadership with proven ability to lead cross-functional teams and influence senior stakeholders.
  • Strong oral and written communication skills for presenting findings, writing quality reports, and communicating with regulators/customers.
  • Analytical thinking and data-driven decision making; ability to convert complex data into actionable plans.
  • Problem-solving mindset with persistence, attention to detail, and a bias for root-cause resolution.
  • Coaching and people development — build high-performing teams and develop technical competency.
  • Project and program management skills including prioritization, resource management, and on-time delivery.
  • Change management and stakeholder alignment to implement new QC systems and behaviors.
  • Customer focus and service orientation to align QC outputs with internal and external customer expectations.
  • Resilience and crisis management ability to lead through quality incidents and time-sensitive escalations.
  • Collaborative mindset to work effectively with Manufacturing, R&D, Regulatory, Supply Chain, and Sales.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Engineering, Applied Science, Chemistry, Biology, Manufacturing Technology, or a related technical discipline.

Preferred Education:

  • Master’s degree in Engineering, Quality Systems, Business Administration, or related field.
  • Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or Six Sigma Black Belt.

Relevant Fields of Study:

  • Industrial Engineering
  • Mechanical Engineering
  • Chemical Engineering / Chemistry
  • Biomedical / Biomedical Engineering
  • Manufacturing Technology
  • Quality Assurance / Regulatory Science

Experience Requirements

Typical Experience Range: 5–12 years of progressive quality or manufacturing experience, with at least 3–5 years in a quality control leadership or program management role.

Preferred:

  • 8+ years in regulated manufacturing environments (medical device, pharmaceutical, biotech, aerospace, automotive, or consumer electronics) with direct ownership of QC programs.
  • Demonstrated experience leading audits, CAPA systems, supplier quality initiatives, and validation projects.
  • Proven track record of delivering measurable improvements in product quality, yield, and cost of poor quality.
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