Senior Quality Assurance Manager

Senior Quality Assurance Manager at Lead Candidate Senior Quality Assurance Manager at Lead Candidate in Carmel, Indiana Posted in 5 days ago.

Type:

full-time

Job Description:

Senior Manager of QA WHO? INCOG is looking for a Senior Manager of QA for Formulation & Filling to join their rapidly growing team. Working closely with the Director of Quality, the Senior Manager will be instrumental in championing and developing INCOG'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. WHAT? 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 role responsibilities are, but are not limited to: 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. 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. 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. YOU! Ideally, candidates will have a Bachelor's degree in a scientific discipline, along with significant experience GMP experience. The successful candidate will have hands-on experience of isolator filling lines, and be a proven leader of leaders. Why INCOG? Paid time off, based on tenure 11 paid holidays 401(k) plan with company match up, vested immediately Choice of health & wellness plans FSA and HSA options Onsite wellness facility Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations Don't meet all the requirements? Don't sweat! We're always looking for an excuse to discuss your next opportunity. You might just surprise yourself... Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.