- Lexington, KYPosition TypeFull TimeEducation Level4 Year DegreeTravel PercentageNoneJob ShiftDayJob CategoryQA
- Quality ControlDescriptionKindeva 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.
-
Manager, Quality Assurance Validation
6 days ago
Kiniksa Pharmaceuticals Lexington, United StatesThis role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote. · **Responsibilities **_(including, but not limited to)_**: · **Quality Assurance Validation (QAV) Responsibilities**: · - Manage the sustain ...
-
Quality Assurance Engineer
2 weeks ago
T2 Biosystems Lexington, United StatesWe are seeking a bright, energetic and detail-oriented individual to join our team as a Quality Assurance Engineer. This is an exciting role that will serve as the primary quality partner for our instrument manufacturing operations and is responsible for promoting product quality ...
-
Director of Quality Assurance
3 weeks ago
Life Sciences Recruitment Lexington, United StatesLocation: Lexington office. Hybrid schedule: 4 days in-office, 1 day remote. · As the Associate Director of Quality Assurance GMP, reporting to the Executive Director, Quality, you'll manage GMP quality standards for clinical-stage programs. This includes overseeing production a ...
-
Quality Assurance Specialist
6 days ago
Bitwerx, Inc. Lexington, United StatesWho are we? · Bitwerx, Inc. is a team of industry experts focused on designing, building, and supporting innovative software solutions that leverage data to improve the customer journey. Our experience spans many industries with a focus on veterinary and dental, and our partners ...
-
Quality Assurance Specialist
1 week ago
Bitwerx Inc Lexington, United StatesJob Description · Job DescriptionWho are we? · Bitwerx, Inc. is a team of industry experts focused on designing, building, and supporting innovative software solutions that leverage data to improve the customer journey. Our experience spans many industries with a focus on veterin ...
-
Quality Assurance Specialist
1 week ago
Bitwerx, Inc. Lexington, United StatesWho are we? Bitwerx, Inc. is a team of industry experts focused on designing, building, and supporting innovative software solutions that leverage data to improve the customer journey. Our experience spans many industries with a focus on veterinary and dental, and our partners ra ...
-
Employee in Quality Assurance
4 days ago
Skyline Solutions Cynthiana, KY, United States Freelance**Why team KRAFT?** · Modern HR experts. team KRAFT - that's us. Our superpower is making your job our job. We bring people and companies together, every day. Our team provides and places candidates in the fields of office, industry, crafts, and information technology. But more i ...
-
Senior Quality Assurance Manager
2 weeks ago
Kindeva Drug Delivery Lexington, United StatesKindeva 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 commercial ...
-
Senior Quality Assurance Specialist
3 weeks ago
T2 Biosystems Lexington, United StatesSenior Quality Assurance Specialist · Department: Quality Assurance · Employment Type: Full Time · Location: Lexington, MA · Reporting To: David Tessein · Description · We are seeking a collaborative and detail-oriented individual to join our team as a Sr. Quality Assurance ...
-
Director, Quality Assurance GMP
3 weeks ago
Kiniksa Pharmaceutical Lexington, United StatesReporting to the Executive Director, Quality, the Director, Quality Assurance GMP will be responsible for GMP quality oversight for Kiniksa's commercial-stage programs, including activities conducted at contract service providers. Scope includes manufacture of cell banks, drug su ...
-
Senior Quality Assurance Manager
2 weeks ago
Kindeva Drug Delivery Lexington, United StatesKindeva 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 commercial ...
-
Manager, GCP Quality Assurance
3 weeks ago
Wave Life Sciences Lexington, United StatesJob DescriptionWave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver s ...
-
Senior Quality Assurance Manager
2 weeks ago
Kindeva Drug Delivery Lexington, United StatesKindeva 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 commercial ...
-
Manager, GCP Quality Assurance
2 weeks ago
Wave Life Sciences Lexington, United StatesJob Description · Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliv ...
-
Senior Manager of Quality Assurance
6 days ago
Kindeva Drug Delivery Lexington, United StatesJob Details · Level · Management · Job Location · Company Headquarters - Lexington, KY · Position Type · Full Time · Education Level · 4 Year Degree · Travel Percentage · None · Job Shift · Day · Job Category · QA - Quality Control · Description · Kindeva is a lead ...
-
Software Quality Assurance Specialist
2 weeks ago
Bitwerx, Inc. Lexington, United StatesWho are we? · Bitwerx, Inc. is a team of industry experts focused on designing, building, and supporting innovative software solutions that leverage data to improve the customer journey. Our experience spans many industries with a focus on veterinary and dental, and our partners ...
-
Senior Quality Assurance Engineer
1 week ago
T2 Biosystems Lexington, United StatesJob Description · Job DescriptionDescriptionWe are seeking a bright, energetic and detail-oriented individual to join our team as a Senior Quality Assurance Engineer. This is an exciting role that will serve as the quality partner for our engineering and instrument manufacturing ...
-
Senior Manager of Quality Assurance
1 week ago
Kindeva Drug Delivery/Summit Biosciences Lexington, United StatesJob Description · Job DescriptionKindeva 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 devel ...
-
Software Quality Assurance Specialist
2 weeks ago
Bitwerx Inc Lexington, United StatesJob Description · Job DescriptionWho are we? · Bitwerx, Inc. is a team of industry experts focused on designing, building, and supporting innovative software solutions that leverage data to improve the customer journey. Our experience spans many industries with a focus on veterin ...
-
Senior Quality Assurance Specialist
1 week ago
T2 Biosystems Lexington, United StatesJob Description · Job DescriptionDescriptionWe are seeking a collaborative and detail-oriented individual to join our team as a Sr. Quality Assurance Specialist. The position reports directly to the Manager, Quality Assurance. · The ideal candidate will be someone that enjoys wor ...
Senior Manager of Quality Assurance - Lexington, United States - Kindeva Drug Delivery
Description
Job DetailsLevelManagementJob LocationCompany HeadquartersJob 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:
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 siteInspire transformative thinking and motivate employees to deliver benchmark performanceDevelop 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 findingsDevelop and monitor quality performance metrics.
Assure compliance with all company SOPs, directives, policies, testing requirements, and regulatory agency guidelines and expectationsLead and foster an environment of continuous improvement in all functions/systems at the siteContribute to and support overall site goals and initiativesDevelop and share best practices and collaborate throughout the organization to implement continuous quality, efficiency and cost-saving initiativesServe as resident current good manufacturing practices (cGMP) QA expert in support of document control, change control, and validationSupport plant management groups on new products and changes to products, processes, and services to achieve a consistent approach to qualityDirect quality and compliance process improvements and goals using current regulations and demonstrated best practicesHire, train, and develop staff and conduct Performance Reviews to ensure highly effective, team-oriented contributors to the company's successProvide information to customers on quality systems and quality improvement plans.
Interact with Clients and Partners to ensure customer satisfactionProvide QA input to technology transfersProvide QA oversight and follow-up on non-product specific incidents related to utilities, facilities, and equipmentParticipate in all plant activities to ensure cGMP-compliant manufacturing and regulatory inspection readinessLead internal and external GMP audits, including the timely preparation of audit reports and responsesLead vendor auditing and qualification programAdvise senior management on findings and recommendations related to qualityPerform Manufacturing Batch review and dispositionMaintain current knowledge of regulatory developmentsOversee out-of-specification investigations and batch deviations along with implementation of respective corrective and preventive actionsProvide oversight of DEA-controlled substance inventories, SOPs, and reports.
Assure compliance with DEA controlled substance regulations including registrations, reporting, and documentation.QualificationsBS in chemistry, biology, or a related field10+ years of GMP quality experience5 years of supervisory/management experienceExtensive technical experience in the analysis and development of pharmaceuticalsExcellent technical writing, project management, and organizational skillsSuperior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organizationFamiliar with the necessary components of facility qualification and validation activitiesExtensive knowledge of cGMP regulations and ICH guidelinesFlexible, adaptable, self-motivated, and able to work well independently and across teamsAbility to work in a lean, action-oriented organization and demonstrate a strong work ethicAbility to identify the need for and implement change while inspiring confidence and enthusiasm within the teamExperience in developing specifications for raw materials and finished productsQualified to work with controlled substancesDemonstrated ability to make and act on decisions while balancing speed, quality, and riskSignificant knowledge in drug product manufacturing, quality assurance, validation, quality control, regulatory affairs, and technology transferAbility to think clearly and decisively; remain calm under adverse conditionsDemonstrated ability to work independently or in groups in a complex, changing environmentAbility to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitmentsAbility to provide innovative, compliant ideas, or alternatives that create value, including seeking new information and external insights
