Director of Quality Assurance

2 weeks ago

Fishers, United States INCOG BioPharma Services Full time

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.

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