- Lead the development, implementation, and management of GMP quality and compliance processes and policies, including the timely development of QA processes and procedures.
- Manage the day-to-day activities of the QA group with respect to the writing, review, and approval of GMP documentation and business practices.
- Lead efforts to ensure the site operates in compliance with internal policies, health authority/regulatory regulations, and evolving expectations. Interact with teams and lead continuous improvement projects, partner with Operations to ensure on-time delivery of quality products.
- Establish the quality plan, strategy, and objectives for the site
- Inspire transformative thinking and motivate employees to deliver benchmark performance
- Develop and Chair the site quality management review board to continuously improve quality and compliance performance by reviewing KPIs and sharing best practices, lessons learned, evolving regulations/expectations, and inspection findings
- Develop and monitor quality performance metrics.
- Assure compliance with all company SOPs, directives, policies, testing requirements, and regulatory agency guidelines and expectations
- Lead and foster an environment of continuous improvement in all functions/systems at the site
- Contribute to and support overall site goals and initiatives
- Develop and share best practices and collaborate throughout the organization to implement continuous quality, efficiency and cost-saving initiatives
- Serve as resident current good manufacturing practices (cGMP) QA expert in support of document control, change control, and validation
- Support plant management groups on new products and changes to products, processes, and services to achieve a consistent approach to quality
- Direct quality and compliance process improvements and goals using current regulations and demonstrated best practices
- Hire, train, and develop staff and conduct Performance Reviews to ensure highly effective, team-oriented contributors to the company's success
- Provide information to customers on quality systems and quality improvement plans.
- Interact with Clients and Partners to ensure customer satisfaction
- Provide QA input to technology transfers
- Provide QA oversight and follow-up on non-product specific incidents related to utilities, facilities, and equipment
- Participate in all plant activities to ensure cGMP-compliant manufacturing and regulatory inspection readiness
- Lead internal and external GMP audits, including the timely preparation of audit reports and responses
- Lead vendor auditing and qualification program
- Advise senior management on findings and recommendations related to quality
- Perform Manufacturing Batch review and disposition
- Maintain current knowledge of regulatory developments
- Oversee out-of-specification investigations and batch deviations along with implementation of respective corrective and preventive actions
- Provide oversight of DEA-controlled substance inventories, SOPs, and reports. Assure compliance with DEA controlled substance regulations including registrations, reporting, and documentation.
- BS in chemistry, biology, or a related field
- 10+ years of GMP quality experience
- 5 years of supervisory/management experience
- Extensive technical experience in the analysis and development of pharmaceuticals
- Excellent technical writing, project management, and organizational skills
- Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
- Familiar with the necessary components of facility qualification and validation activities
- Extensive knowledge of cGMP regulations and ICH guidelines
- Flexible, adaptable, self-motivated, and able to work well independently and across teams
- Ability to work in a lean, action-oriented organization and demonstrate a strong work ethic
- Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team
- Experience in developing specifications for raw materials and finished products
- Qualified to work with controlled substances
- Demonstrated ability to make and act on decisions while balancing speed, quality, and risk
- Significant knowledge in drug product manufacturing, quality assurance, validation, quality control, regulatory affairs, and technology transfer
- Ability to think clearly and decisively; remain calm under adverse conditions
- Demonstrated ability to work independently or in groups in a complex, changing environment
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments
- Ability to provide innovative, compliant ideas, or alternatives that create value, including seeking new information and external insights
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Senior Quality Assurance Manager - Lexington, United States - Kindeva Drug Delivery
Description
Kindeva is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows.
Job Summary:
The Senior Manager of Quality Assurance at Kindeva Drug Delivery/Summit Biosciences will be responsible for ensuring the highest level of quality and compliance for all products and processes at our Lexington, Kentucky facility. This individual contributor role will play a critical role in developing and maintaining quality systems, managing audits and inspections, and driving continuous improvement initiatives. The ideal candidate will have a strong background in quality assurance, strong leadership skills, and a passion for driving excellence in the pharmaceutical industry.
Compensation & Benefits:
This is a full-time position with a competitive salary and benefits package. Benefits include medical, dental, and vision insurance, 401K with company match, paid time off, and opportunities for career growth and development.
Responsibilities:
Requirements:
EEOC Statement:
Kindeva Drug Delivery/Summit Biosciences is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
