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Company

Original Job Post

Insmed Incorporated · 2 days ago

Quality Assurance Director - QC Oversight

Bridgewater, NJ

Full-time

Hybrid

Director

$171K/yr - $240K/yr

10+ years exp

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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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Sterile drug productTabletsBiologicsGene therapyCGMPsRegulatory requirementsFDA/ICH guidelinesQC laboratory equipmentRoot cause analysisAuditsQC validation documentsProject managementMicrosoft OfficeProblem-solvingCommunicationCoachingOrganizationAttention to detail

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.

Founded in 1988

Bridgewater, New Jersey, USA

501-1,000 employees

http://www.insmed.com

H1B Sponsorship

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Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (12)

2022 (8)

2021 (3)

2020 (4)