Overview:
The Senior Director of Quality Assurance will be responsible for effective operation of one or more QA teams at GLP regulated sites. This role will be a pivotal in building strong partnerships with the quality team and our operational leadership.
Responsibilities:
- Responsible for effective operation of one or more QA teams at regulated sites including supervision of staff and their development and growth.
- Craft strong partnerships with quality, operational, scientific and leadership roles across the organization and serve as an influential leader of the DSA organization.
- Resolve problems and collaborate with other department directors and staff on complex issues or when resolution requires input and support from other groups.
- Mentor and coach QA staff to expand skill set and provide opportunities.
- Maintain knowledge of current regulatory requirements, guidelines and best practice, and support growth of the QA team knowledge base in this area.
- Actively participate in relevant external professional organizations.
- Develop a program to provide flexible audit support across sites.
- Develop, implement and monitor inspection/audit training program for QA staff including implementation of cross-site audit program.
- Develop and oversee a RQAP certification training program for QA auditing staff.
- Implement and maintain a training program for the DSA team including regulatory GLP training and refresher program for operations staff.
- Lead/undertake “mock” regulatory inspections for individual sites as requested.
- Support the implementation of the new Quality Management System across Inotiv via targeted projects aimed at harmonizing processes and improving efficiency.
- Ensure that new QMS practices are embedded in the organization.
- Drive process improvement activities aimed at aligning QA practices across Inotiv.
- Provide direct auditing support of equipment qualification and computer validation as needed.
- Serve as back-up to individual QA site managers on ad hoc basis.
- Support due diligence for GXP-related aspects of corporate due diligence initiatives.
- Serve as customer liaison for client audits and corporate quality discussions with potential customers.
- Hosts and/or participates in client and regulatory agency inspections and audits as required.
- Other duties as assigned.
Qualifications:
B.S. or B.A. degree in Biology, Life Sciences, Chemistry or related field and at least 5 years experience CRO industry and 5+ years of managerial experience. Masters preferred. RQAP-GLP preferred.
Detailed knowledge of GLP’s and regulatory agency guidelines (e.g. FDA, AAALAC, etc.).
Excellent written and oral communication skills.
Proficiency in basic computer applications such as email, MS Word and Excel.
Strong attention to detail.
Ability to read, write, speak and understand English.
*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.
Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.
Inotiv has been named a 2023 Top Workplace!
Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!
Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.
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