Assoc. Director, Quality - Commercial
Kiniksa Pharmaceuticals
2 days ago
Remote friendly (Lexington, MA)
United States
$186,000 - $200,000 USD yearly
Operations
Responsibilities:
- Provide Quality oversight/approval for GMP technical transfer activities (clinical→commercial, site-to-site, CMO/CDMO) for Drug Substance and Drug Product.
- Ensure tech transfer strategies, protocols, reports, and control plans meet GMP, data integrity, and regulatory expectations.
- Serve as Quality lead/SME for tech transfer; escalate quality risks timely.
- Review/approve transfer documents: process descriptions, CPPs, CQAs, control strategies, acceptance criteria; Tech Transfer Protocols & Final Reports.
- Ensure comparability, validation, and verification strategies are defined/executed.
- Confirm Quality readiness for PPQ, conformance, and commercial launch.
- Approve GMP documentation (process validation, executed batch records, risk assessments such as FMEA/HACCP, change controls, deviations, CAPAs).
- Align transfers with regulatory submissions (IND, IMPD, NDA/BLA, MAA) and approve supporting documentation.
- Provide oversight for CMO/CDMO onboarding/qualification, audit support, and Quality Agreements/escalation pathways.
- Lead/execute GMP quality systems activities (deviations/investigations, CAPA, change control, batch review, CPV, OOS/OOT, stability programs).
- Participate in regulatory inspections and partner audits; develop/improve Quality systems/SOPs; drive lessons learned/knowledge management; mentor teams; host inspections.
Qualifications:
- 10+ years in pharma/biotech (DS/DP manufacturing, development, and quality) + GxP training.
- Experience in DS/DP manufacturing and tech transfer; managing external partners and batch certification to market.
- Knowledge of worldwide cGMP and quality systems; in-depth EU directives, ICH, global GMP/GDP, and Swiss MPLO 812.12.1.
- Experience with cross-geography teams and pre-/post-approval regulatory authority interactions.
- Strong compliance/ethics; detail-oriented, solution-oriented; Microsoft Office proficiency; travel up to 10%.
Pay range: $186,000–$200,000.
Application instruction: Contact to request reasonable accommodation for the interview/application process.
- Provide Quality oversight/approval for GMP technical transfer activities (clinical→commercial, site-to-site, CMO/CDMO) for Drug Substance and Drug Product.
- Ensure tech transfer strategies, protocols, reports, and control plans meet GMP, data integrity, and regulatory expectations.
- Serve as Quality lead/SME for tech transfer; escalate quality risks timely.
- Review/approve transfer documents: process descriptions, CPPs, CQAs, control strategies, acceptance criteria; Tech Transfer Protocols & Final Reports.
- Ensure comparability, validation, and verification strategies are defined/executed.
- Confirm Quality readiness for PPQ, conformance, and commercial launch.
- Approve GMP documentation (process validation, executed batch records, risk assessments such as FMEA/HACCP, change controls, deviations, CAPAs).
- Align transfers with regulatory submissions (IND, IMPD, NDA/BLA, MAA) and approve supporting documentation.
- Provide oversight for CMO/CDMO onboarding/qualification, audit support, and Quality Agreements/escalation pathways.
- Lead/execute GMP quality systems activities (deviations/investigations, CAPA, change control, batch review, CPV, OOS/OOT, stability programs).
- Participate in regulatory inspections and partner audits; develop/improve Quality systems/SOPs; drive lessons learned/knowledge management; mentor teams; host inspections.
Qualifications:
- 10+ years in pharma/biotech (DS/DP manufacturing, development, and quality) + GxP training.
- Experience in DS/DP manufacturing and tech transfer; managing external partners and batch certification to market.
- Knowledge of worldwide cGMP and quality systems; in-depth EU directives, ICH, global GMP/GDP, and Swiss MPLO 812.12.1.
- Experience with cross-geography teams and pre-/post-approval regulatory authority interactions.
- Strong compliance/ethics; detail-oriented, solution-oriented; Microsoft Office proficiency; travel up to 10%.
Pay range: $186,000–$200,000.
Application instruction: Contact to request reasonable accommodation for the interview/application process.