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 (e.g. 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

Additional Skills

• 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