
Senior Quality Control Manager
2 weeks ago
As a Senior Quality Control Manager, you will be responsible for leading the oversight of Quality Control support operations. This includes maintaining oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning), providing direction to Managers and staff that support the equipment, ensuring equipment qualification and maintenance programs are aligned with regulatory agencies requirements, qualified and available for QC laboratory usage.
- Establishing internal requirements for equipment through collaboration with QC partner groups.
- Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups.
- Overseeing preventive and corrective maintenance monitoring programs.
- Managing oversight of the QC external laboratories activities and performance monitoring of external testing laboratories.
- Supervising the issuance and approval of Quality agreements and SLAs with contract labs.
- Verifying that site manufacturing procedures reflect current contract lab utilization.
- Identifying and addressing issues at contract laboratories to QC leadership.
- Sourcing, coordinating, and project managing GMP activities relating to new contract lab introduction.
This role might be ideal for individuals with strong communication and interpersonal skills, demonstrating logical troubleshooting and problem-solving skills, having a detailed understanding of equipment qualification and maintenance activities and industry compliance norms, and enjoying working in a fast-paced environment.
To be considered for this opportunity, applicants should possess a BA/BS in chemistry, biology, or related field with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience.
Key Responsibilities:- Equipment automation and associated projects
- Personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations
This is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
The organization will also provide reasonable accommodation to known disabilities or chronic illnesses of otherwise qualified applicants for employment, unless the accommodation would impose undue hardship on the operation of the business.
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