Senior Quality Control Manager

Quality Control Leadership

§ Direct and manage Quality Control operations supporting commercial and development-stage products.

§ Develop, implement, and maintain QC systems and procedures to ensure compliance with current Good Manufacturing Practices (cGMPs).

§ Provide leadership, coaching, mentoring, and performance management for laboratory personnel.

§ Establish departmental goals, metrics, and continuous improvement initiatives.

§ Serve as Quality Control subject matter expert during regulatory inspections, customer audits, and internal audits.

Analytical Laboratory Management

§ Oversee analytical chemistry testing of raw materials, in-process materials, finished products, and stability samples.

§ Ensure laboratory methods are properly validated, verified, and maintained.

§ Participate directly in laboratory testing activities as needed to support operations and investigations.

§ Review and approve laboratory data, test results, and technical reports.

§ Ensure compliance with Good Laboratory Practices (GLP) and data integrity requirements.

Microbiology Laboratory Management

§ Manage all microbiology laboratory activities including:

§ Bioburden testing

§ Sterility testing

§ Microbial identification

§ Endotoxin testing

§ Growth promotion testing

§ Water system monitoring

§ Environmental monitoring activities

§ Ensure microbiological methods and procedures are compliant with regulatory requirements and industry standards.

§ Investigate microbiological excursions and contamination events.

Environmental Monitoring and Cleanroom Programs

§ Oversee environmental monitoring (EM) programs for controlled manufacturing environments.

§ Ensure routine monitoring of viable and non-viable particulates, personnel monitoring, and surface sampling programs.

§ Manage cleanroom qualification, certification, and monitoring activities in accordance with ISO 14644 requirements.

§ Analyze environmental trends and implement corrective actions when required.

§ Support contamination control strategies and aseptic processing programs where applicable.

Incoming Materials Inspection

§ Manage receipt, inspection, sampling, testing, and disposition of raw materials, components, packaging materials, and supplies.

§ Ensure supplier quality requirements are met and materials conform to established specifications.

§ Support supplier qualification and quality improvement initiatives.

In-Process and Final Product Testing

§ Oversee execution of in-process controls and final product acceptance testing.

§ Ensure testing activities are completed accurately and within required timelines.

§ Review and approve product release testing data and laboratory records.

Stability Program Management

§ Manage ongoing and accelerated stability programs in accordance with ICH and regulatory requirements.

§ Ensure proper storage, testing, trending, and reporting of stability data.

§ Monitor product shelf-life performance and support expiration dating activities.

§ Prepare stability summaries and annual product quality review inputs.

Investigations and Problem Solving

§ Lead and perform Out of Specification (OOS) investigations , including:

o Phase I Laboratory Investigations

o Phase II Full-Scale Investigations

§ Conduct root cause investigations related to:

o OOT (Out of Trend) results

o Laboratory deviations

o Environmental excursions

o Microbiological contamination events

o Product quality issues

§ Develop and implement effective corrective and preventive actions (CAPA).

§ Utilize risk-based problem-solving tools to identify systemic improvements.

Compliance and Quality Systems

§ Ensure compliance with:

o 21 CFR Part 11 (Electronic Records and Signatures)

o 21 CFR Part 210 (Current Good Manufacturing Practice)

o 21 CFR Part 211 (Finished Pharmaceuticals)

o 21 CFR Part 820 (Quality System Regulation)

o ISO 13485

o ISO 14644

o Good Manufacturing Practices (GMP)

o Good Documentation Practices (GDP)

o Good Laboratory Practices (GLP)

§ Support validation and qualification activities, including laboratory equipment and computerized systems.

§ Monitor laboratory data integrity practices and ensure compliance with ALCOA+ principles.

§ Participate in Management Review and Quality Management System activities.

§ Ensure compliance with GMP, QSR/ISO, FDA, NSF, NRC, ATF, OSHA, and all other regulatory requirements, in accordance with company policy.

§ Regular attendance required.

§ Adhere to company safety requirements.

MINIMUM REQUIREMENTS:

§ Bachelor’s degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related scientific discipline required.

§ Minimum 10 years of progressively responsible Quality Control experience within pharmaceutical, combination product, biotech, or medical device manufacturing environments.

§ Minimum 5 years of leadership or management experience.

§ Demonstrated experience supporting FDA-regulated manufacturing operations.

§ Strong working knowledge of:

o 21 CFR Part 11

o 21 CFR Part 210

o 21 CFR Part 211

o 21 CFR Part 820

o ISO 13485

o ISO 14644

§ Hands-on laboratory experience in both analytical and microbiological testing environments.

§ Extensive experience conducting OOS Phase I and Phase II 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 effectively communicate with regulatory agencies, auditors, customers, and executive leadership.

§ Ability to balance strategic leadership responsibilities with hands-on laboratory support.

§ 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.

PHYSICAL REQUIREMENTS:

§ Frequently required to sit, talk, and hear.

§ Frequently required to stand and walk.

§ Occasionally required to lift up to 20 pounds.

§ Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

§ Ability to travel occasionally by air or car to attend business meetings and conduct audits.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Wage Range $100,000.00-$120,000.00

LIMITATIONS AND DISCLAIMER

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position.

All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.

Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an “at-will” basis.

Silgan is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, or the presence of a disability, which would not prevent the performance of essential job duties with, or without reasonable accommodation of any other protective status.

Silgan is a drug-free workplace.