- Represent Quality Assurance on cross-functional teams, e.g., product development, technology transfer, regulatory dossier preparation, inspection readiness
- Lead and manage a small team of QA professionals, and contribute to their development
- Develop, implement, and improve procedures related to all aspects of GMP manufacturing of commercial materials
- Ensure appropriate quality systems are in place to support product release in a compliant and timely manner, and routinely monitor performance to established targets
- Assist business owners with supplier selection and management
- As required perform supplier qualification and compliance monitoring audits
- Assist in the implementation of quality systems, e.g., deviation, investigation, CAPA, and change control
- Manage Kiniksa's Product Quality Complaint Process; coordinate and conduct product complaint investigations
- Identify and monitor quality system indicators, assuring GMP operations at Kiniksa and contractors are performed in compliance with CGMP
- Prepare for and facilitate regulatory inspections and other external audits
- Perform person-in-Plant functions at CMOs
- Approve master documents e.g. batch records, specifications, etc.
- Evaluate and approve proposed changes in conjunction with change control review board
- Disposition intermediate Products and make recommendations to the Kiniksa Qualified Person for technical release of finished products for Commercial distribution.
- Review and approve complex manufacturing and test records, discrepancy reports, investigations and CAPAs
- Identify and promptly escalate critical risks, and collaborate on quality risk management
- Collaborate with Partners to provide functional expertise in support of commercial stage program opportunities
- Proactively identify improvement opportunities and drive change
- Provide QA support to QC, including lab inspections and method qualification and transfer
- Requires a minimum of 10+ years of relevant experience in a regulated pharmaceutical industry environment and 3+ years in a Quality Assurance leadership role
- Bachelor's degree in science, engineering, biochemistry or related fields, or its equivalent is required
- Extensive knowledge of US and EU CGMP regulations and guidance
- Strong technical expertise in QA/QC, Manufacturing, and Supply Chain processes
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong attention to detail
- Ability to work in a fast paced-environment and to handle multiple tasks
- Strong commitment to compliance and ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 5%
- Salary is commensurate with experience
- Kiniksa Benefits Summary - USA
-
Manager, Quality Assurance Validation
5 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 ...
-
Supervisor, Formulation Manufacturing
5 days ago
Thermo Fisher Scientific Lexington, United StatesAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide o ...
-
Director of Quality Assurance
4 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 at ...
-
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 ...
-
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 ...
-
Senior Manager of Quality Assurance
1 week ago
Kindeva Drug Delivery Lexington, United StatesJob DetailsLevelManagementJob LocationCompany Headquarters - Lexington, KYPosition TypeFull TimeEducation Level4 Year DegreeTravel PercentageNoneJob ShiftDayJob CategoryQA - Quality ControlDescriptionKindeva is a leading global contract developer and manufacturing organization (C ...
-
Director of Quality
1 week ago
Kindeva Drug Delivery Lexington, United StatesJob DetailsJob LocationCompany Headquarters - Lexington, KYPosition TypeFull TimeEducation Level4 Year DegreeJob ShiftDayJob CategoryQA - Quality ControlDescriptionSummary:Responsible for the management of the company's quality assurance and laboratory functions with the goal of ...
-
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 Manager of Quality Assurance
5 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 ...
-
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 ...
-
Director of Quality
1 week ago
Kindeva Drug Delivery Lexington, United StatesJob Summary: · The Director of Quality will oversee all quality assurance and quality control processes at Kindeva Drug Delivery/Summit Biosciences in Lexington, Kentucky. This role is a management position and is responsible for maintaining and improving the company's quality st ...
-
Director of Quality
6 days ago
Kindeva Drug Delivery Lexington, United StatesJob Details · Job Location · Company Headquarters - Lexington, KY · Position Type · Full Time · Education Level · 4 Year Degree · Job Shift · Day · Job Category · QA - Quality Control · Description · Summary: · Responsible for the management of the company's quality as ...
-
Warehouse Supervisor
3 weeks ago
Uniqure NV Lexington, United States**Warehouse Supervisor** · **Location:** Lexington, Massachusetts (US) **Education level:** Bachelor / Graduate **Job category:** Supply Chain **Target start date:** 10/18/2021uniQure is dedicated to bringing innovative therapies for unmet medical needs to patients. In doing so ...
-
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 of Quality
1 day ago
Kindeva Drug Delivery Lexington, United StatesJob Summary: · The Director of Quality will oversee all quality assurance and quality control processes at Kindeva Drug Delivery/Summit Biosciences in Lexington, Kentucky. This role is a management position and is responsible for maintaining and improving the companys quality st ...
-
Director of Quality
1 week ago
Kindeva Drug Delivery/Summit Biosciences Lexington, United StatesJob Summary: · The Director of Quality will oversee all quality assurance and quality control processes at Kindeva Drug Delivery/Summit Biosciences in Lexington, Kentucky. This role is a management position and is responsible for maintaining and improving the company's quality st ...
-
Sterility Assurance Assessment Lead
3 weeks ago
INTELLECTT INC Lexington, United StatesJob Title: Sterility Assurance Assessment LeadLocation: Lexington, MA(Hybrid - Onsite 3 days a week, 2 days from home)Job Description:Execution of a Current State GAP Assessment of the Contamination Control Program of the client from a Global and site-specific perspective.Deliver ...
-
Interim Director Quality
2 weeks ago
The Verity Collective Lexington, United StatesJob Overview: · We are seeking a highly skilled individual to help with all aspects of Quality Operations. This is an interim Associate Director/Director level role and the right candidate must have experience working on early stage (pre-commercial programs). This will be a 6 mon ...
-
Sterility Assurance Assessment Lead
3 weeks ago
INTELLECTT INC Lexington, United StatesJob Title:Sterility Assurance Assessment LeadLocation:Lexington, MAScroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.(Hybrid - Onsite 3 days a week, 2 days from home)Job Description: Executi ...
-
QA/IT Manager
4 weeks ago
Kindeva Drug Delivery Lexington, United StatesJob Details · Job Location · Company Headquarters - Lexington, KY · Position Type · Full Time · Education Level · 4 Year Degree · Job Shift · Day · Job Category · QA - Quality Control · Description · Summary: · Responsible for driving and executing the overall QA strategy ...
Director, Quality Assurance GMP - Lexington, United States - Kiniksa Pharmaceutical
Description
Reporting 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.
The Director collaborates with Technical Operations, Quality Control, Regulatory Affairs, Supply Chain, and other stakeholders, to support and implement phase-appropriate solutions that protect patient safety, enable programs to advance through commercialization to routine commercial supply, and enhance operational effectiveness.
This role is based in our Lexington, MA, 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):
Qualifications:
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.#J-18808-Ljbffr