Insmed Incorporated · 2 days ago
Quality Assurance Director - QC Oversight
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BiotechnologyMedical
H1B SponsorshipGrowth Opportunities
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Responsibilities
Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues.
Responsible for supplier day to day relationships of critical laboratories. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistency.
Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & procedures
Lead overall management of Quality Assurance programs to support the QC lab and to ensure they are meeting expectations, which include oversight of raw material qualification, lab investigations, stability program, etc
Provide oversight of QC equipment program, which includes qualification, calibration, PM, etc
Review and approve deviations, CAPAs, SOPs and Change Control related to QC Lab operations
Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP).
Manage the performance and development of 0-5 direct reports.
Support supplier and internal audits as necessary.
Act as company’s representative during regulatory agencies and customer inspections.
Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.
Support Statistical Trending of Manufacturing and Analytical Data.
Other responsibility as assigned by manager
Qualification
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Required
BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 10 years of relevant Quality Assurance experience; advanced degree and a minimum of 8 years relevant experience required
Experience in sterile drug product, tablets, biologics, gene therapy preferred
Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing
Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines
Solid knowledge of all QC laboratory equipment
Direct experience with investigations and root cause analysis in pharmaceutical or medical device products
Experience with internal and external audits
Experience reviewing QC validation documents
Demonstrate ability to manage projects and variable workloads
Excellent communication and coaching skills (verbal and written)
Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Preferred
Experience in sterile drug product, tablets, biologics, gene therapy
Direct experience with investigations and root cause analysis in pharmaceutical or medical device products
Experience with internal and external audits
Experience reviewing QC validation documents
Some travel may be required - 10%
Benefits
Flexible approach to where and how we work, regionally based
Competitive compensation package including bonus
Stock options and RSU awards
Employee Stock Purchase Plan (ESPP)
Flexible Vacation Policy
Generous paid holiday schedule and winter break
401(k) plan with company match
Medical, dental, and vision plans
Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity insurance
Employee Assistance Program (EAP)
Mental Health on-line digital resource
Well-being reimbursement
Paid leave benefits for new parents
Paid time off to volunteer
On-site, no-cost fitness center at our U.S. headquarters
Company
Insmed Incorporated
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases.
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (12)
2022 (8)
2021 (3)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$3.16BKey Investors
CureDuchenne Ventures
2023-05-08Post Ipo Equity· $0.5M
2022-10-19Post Ipo Equity· $275M
2022-10-19Post Ipo Debt· $500M
Recent News
2024-06-04
2024-06-04
2024-06-03
Company data provided by crunchbase