The Director of Quality leads the quality unit at the site and is responsible for operational and compliance performance that meets expectations necessary for patient safety, customer satisfaction and growth of the business. The role will be responsible for building a high performing team and systems by addressing all current and future needs and building short and long-term quality plans for the site.
The Quality department fulfills a critical role in the daily activities at the Buenos Aires facility. The primary function of the department is to build, monitor and sustain a robust and effective quality system that delivers reliable, high quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent Pharma Solutions complies with all applicable regulations and guidance world-wide, including but not limited to, good manufacturing practice/quality system requirements of ANMAT, FDA and all other international and/or local regulatory health authorities having oversight over the manufacturing of pharmaceutical, consumer and nutritional products.
Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
Develop, implement and communicate a clear strategic vision for quality to maximize employee focus and develop a competitive advantage. The Director of Quality will maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. The successful candidate will bring an expert-level understanding of quality principles and regulatory knowledge.
The Director of Quality will have proven ability to maintain strong relationships with customers, regulatory organizations and other industry contacts. This will enable the incumbent to anticipate changes in the quality/ regulatory climate, and redesign processes accordingly. It is crucial that this individual quickly gain the credibility and respect of his/her team, customers, and the senior executives of other functional areas within the site and Company, particularly with operational leadership. This will require the ability to satisfy the twin needs of compliance and productivity.
Lead a team of approximately 70+ department personnel and have overall responsibilities for Quality Control, Quality Assurance, Regulatory Compliance, Validation and Training oversight. Must have a demonstrated track record of talent management; building bench strength and setting clear objectives for performance and accountability.
Responsible for the quality aspects associated with materials management, manufacturing, packaging, storage and release of all products produced at the site. The Director of Quality is also responsible for compliance to global standards of cGMP.
Leads Quality Strategic Planning and Quality yearly objective setting that meet compliance requirements and business needs.
Assures that systems are in place in all areas of technical operations to achieve compliance with cGMP regulations and corporate quality standards.
Oversees laboratory operations, responsible for testing/inspecting and releasing materials for use in product manufacturing and packaging and final product testing.
Minimum Bachelor of Science, MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology with 10+ years’ experience in pharmaceutical quality assurance, compliance and quality control.
Experience in the development of innovative and action-oriented quality programs are critical.
Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment
Must have a demonstrable record of implementing and maintaining quality systems; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics.
Catalent’s Standard Leadership Competencies
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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