Description
We are seeking a Director of Quality Assurance that has a passion for leading people and processes, and is familiar with transformational, situational, and servant leadership concepts. The Director will support continuous personal and professional development of QA staff through meaningful goal setting, performance management, and career development plans.
The Director of Quality Assurance will work closely with the VP, Quality, Director of Quality Control, and Senior Director of Operations and will lead strategy and direction of the QA function to partner cross-functionally to ensure that manufacturing operations and QC testing are being performed and documented in compliance with global health authority regulations and expectations, as well as INCOG procedures.
The Director will be influential in championing and developing our Quality Mindset through ingrained quality with skills including attention to detail, on time delivery, and efficiency into the Quality Assurance organization you will help build. Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The Director will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners. The Director will thrive in a team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the Director will possess a demonstrated ability to influence positive outcomes without direct reporting authority.
Essential Job Functions:
•Execute and maintain Quality Assurance oversight of manufacturing, packaging, and quality control testing activities.
•Ensure that key QA functions (batch release, material release, data review, validation oversight, manufacturing QA) are performed and documented in compliance with global health authority regulations and expectations, as well as INCOG procedures.
•Provide review and/or approval of master batch records, deviations, and CAPAs related to areas of oversight.
•Maintain responsibility for QA metrics development, management, and reporting.
•Participate in material planning and Ready to Execute meetings to ensure QA items are ready, as well as partner with other departments (MSAT, Supply Chain, QC, Validation) to ensure their deliverables meet global health authority regulations and expectations, as well as INCOG procedures.
•Participate in business development meetings / discussions with INCOG clients representing QA and INCOG's quality systems.
•Participate in client and regulatory audits as required.
•Participate in routine client meetings to represent QA and INCOG's quality systems.
•Act as the delegate for the VP Quality as needed.
•Utilize various paper and automated systems (QMS, LIMS, etc.) to manage local QA and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
Special Job Requirements:
•Bachelor's degree in science.
•Minimum of 15 years of biopharma industry experience, of which at least 5 years have been in a role of hands-on experience with Quality Assurance in aseptic manufacturing facilities.
•Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for aseptic manufacturing facilities.
•Experience with leading initiatives to drive a culture of delivery and compliance within a regulated manufacturing environment.
•Possess skills in leadership, communication, project management and budget management, while maintaining extremely high quality and efficiency standards.
•First-hand experience participating in and/or hosting audits/inspections.
•Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.).
Additional Preferences:
•Experience with high growth companies.
•Experience with packaging and labeling operations, inclusive of serialization.
•Experience with combination products regulations.
•Previous supervisory experience.
•Previous experiencing mentoring and developing people leaders
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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