Senior Manager of Quality Assurance
Description
The Senior Manager will lead or be a primary partner in programs for:
• Quality Oversight of Formulation and Filling Operations
• Aseptic Manufacturing / Sterility Assurance
• Contamination Control Strategy (CCS)
• Review of Operational, Quality Control or other SOPs
• Deviation triage, tracking/trending, and investigation support
Working closely with the Director of Quality, the Senior Manager will be instrumental in championing and developing our new organization’s Quality Mindset, as well as a culture of effectiveness, attention to detail, and on-time delivery. The Senior Manager will need to successfully navigate audits and identify operational and quality gaps.
The Senior Manager will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners. The Senior Manager will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Senior Manager will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The Senior manager will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
Essential Job Functions:
• Recruit, build, and lead a QA Operations Formulation & Filling team.
• Responsible for training and maintaining an engaged work force competent in both theory and application of Quality processes to support a state-of-the-art aseptic drug product manufacturing facility.
• Lead through coaching, mentoring, and maintaining an on-the-floor presence in operations to ensure rigorous quality work standards and quality product manufacture.
• Lead development of room/line clearance processes for formulation and aseptic filling areas.
• Train QA team members on gowning and area contamination controls, aseptic operational line process and equipment applications and verifications.
• Lead strategy and direction of the Quality Assurance team to partner with Operations in the performance of on-the-floor batch record review and correction.
• Establish an ongoing state of readiness in the exercising of rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions.
• Serve as a site subject matter expert in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
• Partner with EH&S and Operations management in using positive and proactive approaches to communicate safety expectations, assess safety behaviors, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
• Partner with Operations management in applying knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness on the operations floor, and act as a key point-of-contact for regulatory agencies during inspections and audits.
• Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
Special Job Requirements:
• Bachelor’s Degree required; degree preferred to be in Science (Chemistry, Biology, Chemistry, etc.)
• Minimum of 5 years of Quality Assurance experience in biopharma or similarly regulated industry.
• Expert level of understanding and oversight of contamination controls, manufacturing processes, and output quality using automated and non-automated manufacturing systems with associated data integrity requirements. Prior experience and comfort with making risk-based decisions to ensure product quality required.
• Possesses an excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Operations and Quality.
• Exceptional computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
Additional Preferences:
• Advanced Degree
• Certification(s) in Risk Management, Quality Process Analysis, Technical Writing, and/or Quality Investigation.
• Hands-on experience with aseptic manufacturing Quality.
• Isolator-based aseptic processing experience.
• 2+ years of experience as a people leader or supervisor.
• First-hand experience participating in and/or hosting operation floor inspection tours related to Quality Assurance.
• Experience with building processes and procedures.
• Experience with Continuous improvement, Six Sigma, and/or Lean principles.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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