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Director, Quality Systems
Location:
Bloomington
Description:
Position Summary The Director of Quality Systems is responsible for managing pharmaceutical quality systems governance. Reporting to the VP of Quality, the Director of Quality Systems will manage all quality systems, governance and continuous improvement as it relates to Quality Management Systems for execution of contract development and manufacturing operations on behalf of Catalent Indiana's client base. The Role Provide leadership and strategic direction in the development, implementation, and maintenance and governance of quality systems and documentation, as well as other process improvement initiatives, in compliance with GxP regulations Possess a strong background in regulatory compliance, expertise in quality management systems and document control processes, attention to detail, and the ability to collaborate cross-functionally and communicate effectively Lead and manage quality systems, document control function, and supplier quality functions ensuring alignment with company goals and objectives Support GxP functions by developing and implementing policies, procedures, and processes to ensure compliance with regulatory requirements Responsible for QA oversight for health, use and control for management and use of the electronic Quality Management systems at Site Collaborate with cross-functional teams to ensure the successful quality initiatives and integration of quality systems, and documentation into all aspects of the organization. Conduct risk assessments and gap analyses to identify areas for improvement in quality systems and documentation practices Monitor the performance of the quality management system through the use of key performance indicators (KPIs), metrics, effectiveness checks, and management review to identify trends and areas for improvement Host the Quality Management Review, and establish and measure associated metrics, for the holistic governance and documentation of quality oversight Responsible for the management of audits (internal and client) and regulatory inspections, commitments, and risk management Develop and implement programs for internal quality system improvement and continuous improvement culture Manage a large quality team, define department goals and metrics Manage department contract negotiation and review for vendors and contract staff The Candidate Bachelor's degree in chemistry, organic chemistry, biochemistry, or other relevant scientific discipline, or above 20 years relevant Quality experience in Pharmaceutical including demonstrated success at Senior Quality leadership level; advanced degree preferred 10+ years of QA experience in the pharmaceutical industry or a combination of pharmaceutical and other related FDA/EU regulated industry Experience with a range of dosage forms, including biologics, liquid sterile, and lyophilized product Demonstrated experience in selecting, implementing, and managing electronic Quality Management Systems Knowledge of GxP regulations, with prior experience supporting GMP operations (e.g. reviewing batch records, managing quality events) Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams Excellent communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization Strong analytical and problem-solving skills, with the ability to identify and address complex issues in a timely manner Ability to thrive in a fast-paced and dynamic environment, with a commitment to continuous improvement Progressive management experience in pharmaceutical quality, ultimately leading a quality team of significant size ASQ certification preferred Six Sigma GMP QA experience A depth of FDA-facing experience in managing both internal audits and external audits and inspection A track record of accomplishment in managing multiple competing priorities on tight timelines Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience. Why You Should Join Catalent Defined career path and annual performance review and feedback process Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Dynamic, fast-paced work environment Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement GymPass program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.personal initiative. dynamic pace. meaningful work.Visit Catalent Careers to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to XXXX@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to XXXX@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE .
Company:
Catalent
Posted:
March 6 on HireLifeScience
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More About this Listing: Director, Quality Systems
Director, Quality Systems is a Executive Director Job at Catalent located in India. Find other listings like Director, Quality Systems by searching Oodle for Executive Director Jobs.
Director, Quality Systems is a Executive Director Job at Catalent located in India. Find other listings like Director, Quality Systems by searching Oodle for Executive Director Jobs.