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About the Role

This multi-disciplinary management role oversees all aspects of compliance for the manufacture of sterile injectables, including laboratory operations, documentation, regulatory inspections, supplier quality, and continuous improvement initiatives. The position interacts with all organizational levels, both domestically and internationally.

Responsibilities

• Provides leadership and direction for a professional team focused on quality management systems and compliance.
• Establishes and maintains performance goals, training plans, and provides regular feedback.
• Performs all duties in accordance with American Regent’s Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Owns Quality Management for Deviation, CAPA, Change Control, Documentum Control, Annual Product Review Systems, Technical Services, and External Manufacturers (CMOs).
• Leads Quality activities to execute production records, approve executed batch records, and support product release for shipment.
• Manages and improves ARI’s Quality Systems to ensure compliance with regulatory requirements and provide safe and effective products.
• Ensures site-wide cGMP compliance in accordance with 21 CFR Parts 210 and 211, USP requirements, and other regulatory requirements.
• Identifies and facilitates the resolution of quality issues in conjunction with site teams.
• Manages all aspects of regulatory authority inspections, customer and corporate audits, develops responses, and executes required improvements.
• Owns and supports metrics-based Continuous Quality Improvement activities and Key Performance Indicators (KPIs) through statistical methodology.
• Provides oversight for review and release of commercial, R&D, and clinical study products.
• Maintains and manages communications and cross-functional activities with internal/external customers and regulatory agencies.
• Drives continuous improvement initiatives for the site and collaborates with other ARI locations to ensure best practices and policy harmonization.
• Drives quality culture and Core Competency Model initiatives to enhance organizational performance.
• Responsible for Quality Control (Stability, Chemistry, Microbiology, EM, & QC Particulate labs) for the site.
• Manages and facilitates the QA Operations, QA Inspection, and Finishing teams to ensure timely and quality oversight of production activities.
• Partners with Production, Regulatory Affairs, Engineering, R&D, and QA Compliance to strategize and implement new technology, processes, and products.
• Leads on-site QA activities in investigating deviations, CAPAs, or other compliance issues associated with daily inspections/packaging operations.
• Writes and revises SOPs and other cGMP documentation.
• Ensures all work is performed and documented in accordance with company policies, procedures, cGMP, and health and safety requirements.
• Performs other tasks/duties as assigned by management.

Requirements

• Bachelors in Life Science or equivalent course of study required.
• Master’s Degree is a plus.
• Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies.
• Minimum 10 years leading functional quality assurance, quality control, compliance, or manufacturing operations.
• Expertise across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, and validation for pharmaceutical manufacturing facilities.
• Understands the standards and principles of Compliance and Quality Assurance, including specific regulatory requirements and techniques for examining, questioning, evaluating, and reporting on quality system adequacy and deficiencies.
• Thorough understanding of applicable regulations/guidelines/expectations and proven ability to apply them to a pharmaceutical environment.
• Proven excellence in written and verbal communication skills.
• Proven record of exceptional people and program management skills.
• Ability to work independently and deliver timely results.
• Ability to work off hours and weekends as needed.
• Able to travel 10% of the time.
• Occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
• Able to occasionally lift and/or move up to 25 pounds.
• Physically able to wear cleanroom/protective gowning and equipment, including gowning, goggles, face shields, and protective gloves.

Skills

• Quality Management Systems
• Compliance
• Laboratory Operations
• Documentation
• Regulatory Body Inspections (FDA, Health Canada, etc.)
• Supplier Quality
• Third Party Manufacturer Quality
• Strategic Quality Initiatives
• Continuous Improvement Processes
• Deviation Management
• CAPA Management
• Change Control
• Documentum Control
• Annual Product Review Systems
• Technical Services
• External Manufacturer Quality Management
• cGMP Compliance
• Statistical Methodology
• Metrics-based Continuous Quality Improvement
• Key Performance Indicators (KPIs)
• Product Release
• Regulatory Affairs Collaboration
• Engineering Collaboration
• R&D Collaboration
• QA Compliance Collaboration
• Process Improvement
• New Technology Implementation
• New Process Implementation
• New Product Implementation
• Investigation of Deviations
• Investigation of CAPAs
• SOP Writing
• SOP Revision
• cGMP Documentation
• Health and Safety Requirements
• People Management
• Program Management
• Written Communication
• Verbal Communication

Location

• Domestic
• International

Work Type

• Full-time

Experience Level

• Minimum 15 years progressive experience in pharmaceutical operations and interactions with regulatory agencies.
• Minimum 10 years leading functional quality assurance; quality control, compliance, or manufacturing operations.

Education Level

• Bachelors in Life Science or equivalent course of study
• Master’s Degree

About the Company

• American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees.
• American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users.

Equal Opportunity

• We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
• Applicants have rights under Federal Employment Laws.
• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf