78 applicants

Company

Original Job Post

KBI Biopharma · 2 days ago

Senior Manager Quality Assurance

Durham, NC

Full-time

Onsite

Senior Level

$130K/yr - $160K/yr

10+ years exp

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Responsibilities

Functions as the system owner for the Deviation, CAPA, and Complaint Quality systems.

Track, trend, compile, and report quality metrics as required.

Provides compliant investigations and review and approve investigations and corrective/preventative actions as needed.

Develop and/or support training materials for Quality Systems to include Deviation/CAPA system and batch record review.

Provide training and certification of QA personnel.

Provides coaching and mentoring to direct reports and QA specialists.

Support Client Audits and Regulatory Inspections as required.

Partners with Program Management, Technical Operations, and AFS, and Manufacturing to provide support.

Communicates with clients, as needed, regarding quality related events.

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.

QACGMPQuality SystemsSupervisory ExperienceFDA RegulationsEU RegulationsROW RegulationsInterpersonal SkillsTeamworkAttention to DetailProblem Resolution

Required

BS in a related field

10+ years experience in QA or cGMP environment

Experience in providing QA support of Quality Systems to include Deviations, CAPAs and Complaints

4+ Years of supervisory experience

Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills

Strong understanding of FDA, EU and ROW cGMP regulations is required

Benefits

Annual bonus structure

Medical, dental, and vision coverage

Paid PTO and holidays

Sabbatical program

401K matching with 100% vesting in 60 days

Employee recognition programs

Company

KBI Biopharma

Glassdoor

3.1

KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help

Founded in 1996

Durham, North Carolina, USA

1,001-5,000 employees

http://kbibiopharma.com

H1B Sponsorship

KBI Biopharma 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)

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Trends of Total Sponsorships

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2020 (20)