Kiniksa Pharmaceuticals
Senior Manager, Supplier Quality Management
Kiniksa Pharmaceuticals, Lexington, Massachusetts, United States, 02173
Senior Manager, Supplier Quality Management
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Senior Manager, Supplier Quality Management
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Kiniksa Pharmaceuticals Senior Manager, Supplier Quality Management
Join to apply for the
Senior Manager, Supplier Quality Management
role at
Kiniksa Pharmaceuticals Get AI-powered advice on this job and more exclusive features. Senior Manager, Supplier Quality Management (SQM)
Reporting to the Associate Director – Supply Quality Management, the Senior Manager, Supplier Quality Management, will be responsible for execution of SQM activities, improving SQM processes, and contributing to SQM Strategy. This role will collaborate with all global GxP groups (Good Clinical, Manufacturing, and Distribution practices) to provide appropriate supplier oversight and relationship management.
This 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)
As part of the SQM team, ensure compliant and on-time execution of SQM activities, such as, but not limited: Global GxP supplier oversight (e.g. on-site audits & remote assessments) Supplier lifecycle management (e.g. on-boarding & off-boarding activities, monitoring supplier risks etc.) Audit deliverables (e.g. communication, reporting & CAPA management) Monitor & maintain SQM systems to ensure constant alignment with regulatory and Kiniksa quality standards Supplier change notifications (SCN) Damaged defective raw materials (DDRM) Create & manage Quality Technical Agreements with global GxP vendors Provide vendor data & support for Kiniksa regulatory obligations. Represent SQM during internal & external inspections. Represent Kiniksa to external parties & internal customers, upholding the highest standards of professionalism and conduct Maintain and improve core SQM processes and systems. Proactively engage with key internal stakeholders to assure the smooth functioning of Kiniksa business operations with respect to suppliers of GxP materials and services. Support & contribute to Kiniksa clinical programs with risk-based evaluation of potential suppliers ensuring timely selection, qualification, and oversight; escalate critical risks to senior management & program teams Maintain awareness of industry compliance trends with the various regulatory agencies as it relates to supplier oversight Independently apply advanced level of skill and broad knowledge of diverse related professional fields to advance SQM performance and overall value to Kiniksa Drive continuous improvement across Quality function and the organization. Embodies Kiniksa’s cultural values and aligns daily actions with departmental goals and company culture.
Qualifications And Experience
Bachelors or Advanced degree in a scientific discipline. 5+ years of relevant experience in a regulated pharmaceutical environment and 2 years focused on GxP Audit. Understanding of worldwide requirements of cGxP and quality systems. In depth knowledge of EU Directives 2001/83/EU, 2001/20/EC, 2003/94/EC, ICH, and global GxP standards. Experience in working with teams in other countries (eg. UK). Established expertise and training in GxP systems and processes. Demonstrated strong written and verbal communication skills Strong team player that has a customer service approach and is solution oriented. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Strong commitment to compliance and ethical standards Ability to travel up to 30%
Competency Expectations
Essential: Fluent in English with excellent verbal and written communication skills, Desirable (if English is not mother tongue): Common European Framework of Reference for Languages (CEFR) certification of C1 Business Higher or equivalent in English Excellent team building, and management skills. Excellent listening, communication and interpersonal skills fostering team spirit. Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Referrals increase your chances of interviewing at Kiniksa Pharmaceuticals by 2x Get notified about new Supplier Quality Manager jobs in
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Join to apply for the
Senior Manager, Supplier Quality Management
role at
Kiniksa Pharmaceuticals Senior Manager, Supplier Quality Management
Join to apply for the
Senior Manager, Supplier Quality Management
role at
Kiniksa Pharmaceuticals Get AI-powered advice on this job and more exclusive features. Senior Manager, Supplier Quality Management (SQM)
Reporting to the Associate Director – Supply Quality Management, the Senior Manager, Supplier Quality Management, will be responsible for execution of SQM activities, improving SQM processes, and contributing to SQM Strategy. This role will collaborate with all global GxP groups (Good Clinical, Manufacturing, and Distribution practices) to provide appropriate supplier oversight and relationship management.
This 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)
As part of the SQM team, ensure compliant and on-time execution of SQM activities, such as, but not limited: Global GxP supplier oversight (e.g. on-site audits & remote assessments) Supplier lifecycle management (e.g. on-boarding & off-boarding activities, monitoring supplier risks etc.) Audit deliverables (e.g. communication, reporting & CAPA management) Monitor & maintain SQM systems to ensure constant alignment with regulatory and Kiniksa quality standards Supplier change notifications (SCN) Damaged defective raw materials (DDRM) Create & manage Quality Technical Agreements with global GxP vendors Provide vendor data & support for Kiniksa regulatory obligations. Represent SQM during internal & external inspections. Represent Kiniksa to external parties & internal customers, upholding the highest standards of professionalism and conduct Maintain and improve core SQM processes and systems. Proactively engage with key internal stakeholders to assure the smooth functioning of Kiniksa business operations with respect to suppliers of GxP materials and services. Support & contribute to Kiniksa clinical programs with risk-based evaluation of potential suppliers ensuring timely selection, qualification, and oversight; escalate critical risks to senior management & program teams Maintain awareness of industry compliance trends with the various regulatory agencies as it relates to supplier oversight Independently apply advanced level of skill and broad knowledge of diverse related professional fields to advance SQM performance and overall value to Kiniksa Drive continuous improvement across Quality function and the organization. Embodies Kiniksa’s cultural values and aligns daily actions with departmental goals and company culture.
Qualifications And Experience
Bachelors or Advanced degree in a scientific discipline. 5+ years of relevant experience in a regulated pharmaceutical environment and 2 years focused on GxP Audit. Understanding of worldwide requirements of cGxP and quality systems. In depth knowledge of EU Directives 2001/83/EU, 2001/20/EC, 2003/94/EC, ICH, and global GxP standards. Experience in working with teams in other countries (eg. UK). Established expertise and training in GxP systems and processes. Demonstrated strong written and verbal communication skills Strong team player that has a customer service approach and is solution oriented. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Strong commitment to compliance and ethical standards Ability to travel up to 30%
Competency Expectations
Essential: Fluent in English with excellent verbal and written communication skills, Desirable (if English is not mother tongue): Common European Framework of Reference for Languages (CEFR) certification of C1 Business Higher or equivalent in English Excellent team building, and management skills. Excellent listening, communication and interpersonal skills fostering team spirit. Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Referrals increase your chances of interviewing at Kiniksa Pharmaceuticals by 2x Get notified about new Supplier Quality Manager jobs in
Lexington, MA . Waltham, MA $140,000.00-$200,000.00 1 week ago Lowell, MA $105,000.00-$125,000.00 5 days ago Andover, MA $102,800.00-$167,050.00 1 week ago Associate Director, Quality Assurance - CDMO
Marlborough, MA $130,000.00-$155,000.00 3 weeks ago Lynn, MA $124,700.00-$207,800.00 6 days ago Marlborough, MA $120,000.00-$199,000.00 1 week ago Director - Manufacturing Site Inspection Management, Quality
Wilmington, MA $75,000.00-$90,000.00 1 day ago Senior Manager Manufacturing (CMC) Quality Assurance
Ayer, MA $80,000.00-$90,000.00 16 hours ago Sr Mgr/Associate Director, GMP Quality Assurance
Nashua, NH $146,670.00-$249,330.00 6 days ago Andover, MA $101,000.00-$203,000.00 1 week ago Composites Advanced Quality Engineer/Zero Defect
Boston, MA $110,500.00-$184,200.00 3 days ago Customer Quality Manager - Electronics Mfg - Lawrence, MA
Lawrence, MA $100,000.00-$140,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr