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Description:
• Provide Quality oversight to biologics Contract Manufacturing Organization (CMO) operations including but not limited to review/approval of CMO batch records, disposition, deviations, CAPAs, change controls, and inspection management.
• Routinely review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC), routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Exercises judgment within well-defined and established procedures and practices to determine appropriate action with minimal supervision.
• Perform Quality Assurance activities to ensure compliance with internal processes and procedures and applicable US and international regulatory requirements in support of current Good Manufacturing Practices (cGMP) operations.
• Accountable for extracting, consolidating, and analyzing data within a specific area of concentration.
• Demonstrates an ability to communicate effectively with peers in CMO Organization
• Maintain routine systems, programs, and processes to ensure high quality products and compliance with cGMP.
• Interface with CMO and site client groups and within the Gilead network to address investigations and quality issues requirements.
• Effectively communicate with external suppliers to address documentation and compliance issues.
• Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
• Write, implement, review, and/or approve changes to controlled documents (e.g., SOPs, specifications, batch records, etc.) to ensure quality objectives are met.
• Track, trend, and report CMO metrics and support site QMR and Executive QMR processes.
• Participate post-inspection risk assessments of CMO regulatory inspections, identify, and implement improvements, as needed.
Additional Skills & Qualifications:
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• 6+ years of experience
• Demonstrates thorough knowledge of FDA / EMEA, other international standards and quality systems, and the interface with other functions like manufacturing, distribution, and maintenance.
• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.
• Demonstrates excellent verbal communication, technical writing, and interpersonal skills.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
• Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
• Prior experience in pharmaceutical industry is preferred.
• Preferred experience working with CMOs.
Experience Level:
Expert Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
