Director of Quality Assurance
Director of Quality Assurance
INCOG BioPharma Services
Fishers, IN
See who INCOG BioPharma Services has hired for this role
Director of QA
WHO
INCOG is 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.
INCOG is offering the opportunity to contribute towards a better path to market for life-saving drugs. Having recently been voted as one of the Best Places To Work in Indiana for the third year in a row, INCOG is the perfect place to continue building your career!
WHAT
Working closely with the VP of Quality, Director of Quality Control, and Senior Director of Operations you will lead strategy and direction of the QA function 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 main aspects of the role will include:
• 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.
YOU
Ideally, the perfect candidate will possess a Bachelor’s degree in science, along with:
• 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.
• Previous experiencing mentoring and developing people leaders
• 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.).
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.
-
Seniority level
Director -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at INCOG BioPharma Services by 2x
See who you knowGet notified about new Director of Quality Assurance jobs in Fishers, IN.
Sign in to create job alertSimilar jobs
People also viewed
-
Director of Quality Management
Director of Quality Management
-
Head of Quality
Head of Quality
-
Director of Quality
Director of Quality
-
Quality Director (Chemicals Industry)
Quality Director (Chemicals Industry)
-
Global Head of Quality
Global Head of Quality
-
Quality Director (Aerospace)
Quality Director (Aerospace)
-
Director, Quality
Director, Quality
-
Director of Quality
Director of Quality
-
Director of Quality Assurance (Food Manufacturing)
Director of Quality Assurance (Food Manufacturing)
-
Quality Director (Aerospace)
Quality Director (Aerospace)
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub