Senior Quality Control Manager

Silgan Dispensing Systems•Spokane, WA

2d•$100,000 - $120,000

About The Position

The Senior Quality Control Manager directs Quality Control operations supporting commercial and development-stage products. The role manages analytical and microbiology laboratory activities, oversees incoming material inspection and in-process and final product testing, and manages stability programs. It provides leadership and performance management for laboratory personnel, establishes departmental goals and continuous improvement initiatives, and serves as a Quality Control subject matter expert during regulatory inspections and audits. The position ensures laboratory methods, equipment, computerized systems, records, and testing activities comply with applicable cGMP, GLP, data integrity, FDA, ISO, and other regulatory requirements. It leads OOS and other quality investigations, develops CAPAs, supports validation and qualification activities, and contributes to Management Review and Quality Management System activities. The role balances strategic leadership with hands-on laboratory support as needed. Regular attendance and adherence to company safety requirements are required.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
At least 10 years of progressively responsible Quality Control experience in pharmaceutical, combination product, biotech, or medical device manufacturing environments.
At least 5 years of leadership or management experience.
Demonstrated experience supporting FDA-regulated manufacturing operations.
Strong working knowledge of 21 CFR Parts 11, 210, 211, and 820; ISO 13485; and ISO 14644.
Hands-on laboratory experience in both analytical and microbiological testing environments.
Extensive experience conducting Phase I and Phase II OOS investigations.
Strong expertise in cGMP regulations and FDA Quality System requirements.
In-depth knowledge of microbiological testing methods and contamination control principles.
Experience with environmental monitoring and cleanroom qualification programs.
Knowledge of stability program design and management.
Strong analytical chemistry and laboratory operations experience.
Experience with laboratory information management systems (LIMS) and electronic quality systems.
Knowledge of statistics and trend analysis for laboratory and environmental data.
Excellent technical writing and investigation skills.
Strong organizational, leadership, and decision-making abilities.
Ability to communicate effectively with regulatory agencies, auditors, customers, and executive leadership.
Ability to balance strategic leadership responsibilities with hands-on laboratory support.
Frequently able to sit, talk, hear, stand, and walk; occasionally able to lift up to 20 pounds.
Vision abilities including close vision, distance vision, color vision, and the ability to adjust focus.
Ability to travel occasionally by air or car for business meetings and audits.

Nice To Haves

ASQ Certified Quality Manager (CMQ/OE), Certified Quality Auditor (CQA), or equivalent certification.
Training in root cause analysis methodologies, including Six Sigma or Lean principles.
Experience with combination products and sterile manufacturing facilities.
Experience leading FDA, ISO, customer, and Notified Body inspections.

Responsibilities

Direct and manage Quality Control operations for commercial and development-stage products.
Develop, implement, and maintain QC systems and procedures to ensure cGMP compliance.
Lead, coach, mentor, and manage the performance of laboratory personnel; establish departmental goals, metrics, and continuous improvement initiatives.
Serve as a Quality Control subject matter expert during regulatory inspections, customer audits, and internal audits.
Oversee analytical chemistry testing of raw materials, in-process materials, finished products, and stability samples; ensure methods are validated, verified, and maintained.
Participate in laboratory testing as needed; review and approve laboratory data, test results, technical reports, and laboratory records.
Manage microbiology laboratory activities, including bioburden, sterility, microbial identification, endotoxin, growth promotion, water-system monitoring, and environmental monitoring testing.
Ensure microbiological methods and procedures meet regulatory requirements and industry standards; investigate microbiological excursions and contamination events.
Oversee environmental monitoring programs for controlled manufacturing environments, including viable and non-viable particulates, personnel monitoring, and surface sampling.
Manage cleanroom qualification, certification, and monitoring in accordance with ISO 14644; analyze environmental trends and implement corrective actions.
Support contamination control strategies and aseptic processing programs where applicable.
Manage receipt, inspection, sampling, testing, and disposition of raw materials, components, packaging materials, and supplies; support supplier qualification and quality improvement initiatives.
Oversee in-process controls and final product acceptance testing, ensuring testing is accurate and completed on time; review and approve product release testing data.
Manage ongoing and accelerated stability programs in accordance with ICH and regulatory requirements, including storage, testing, trending, reporting, shelf-life monitoring, expiration dating support, stability summaries, and annual product quality review inputs.
Lead and perform Phase I laboratory and Phase II full-scale OOS investigations; investigate OOT results, laboratory deviations, environmental excursions, microbiological contamination events, and product quality issues.
Develop and implement effective CAPAs and use risk-based problem-solving tools to identify systemic improvements.
Ensure compliance with applicable regulations and standards, including 21 CFR Parts 11, 210, 211, and 820; ISO 13485 and ISO 14644; GMP, GDP, and GLP; and FDA, NSF, NRC, ATF, OSHA, and other requirements in accordance with company policy.
Support validation and qualification of laboratory equipment and computerized systems; monitor laboratory data integrity and compliance with ALCOA+ principles.
Participate in Management Review and Quality Management System activities.
Maintain regular attendance and adhere to company safety requirements.
Travel occasionally by air or car to attend business meetings and conduct audits.