Manager Quality Control

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 60,000 - 80,000; Full time

Job summary

A global biopharmaceutical company in Munster is seeking a Quality Control Manager to oversee QC operations. Responsibilities include managing the lifecycle of QC equipment, ensuring regulatory compliance, and leading QC validation efforts. The ideal candidate will have a BS in a related field and 8+ years of relevant experience in the pharmaceutical industry. This role offers comprehensive benefits, including health and wellness programs.

Benefits

Health and wellness programs

Fitness centers

Annual bonuses

Paid time off

Qualifications

• 8+ years’ proven experience in the pharmaceutical or biotechnology industry.
• Previous supervisory or leadership experience.
• Enjoy working in a fast-paced environment.

Responsibilities

• Oversee QC equipment lifecycle activities.
• Provide direction to Managers and staff supporting the equipment.
• Ensure equipment qualification aligns with regulatory requirements.
• Interact with QC partner groups to meet internal requirements.
• Lead QC equipment validation through collaboration.

Skills

Strong communication and interpersonal skills

Logical troubleshooting and problem-solving skills

Understanding of equipment qualification

Ability to communicate effectively

Collaborative and team-oriented approach

Education

BA/BS in chemistry, biology or related field

Job description

Overview

Within this role you will be responsible for the oversight of Quality Control support operations.

Responsibilities

• 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

• Interacting with QC partner groups to establish internal requirements for equipment

• Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups

• Managing oversight of the preventive and corrective maintenance monitoring program

• 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 the contract labs

• Verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization

• Identifying and calling out issues at contract laboratories to QC leadership

• Sourcing, co-ordinating and project management of GMP activities relating to new contract lab introduction

• Travel may be required in support of external contract laboratory testing activities

• Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations

• Responsibility for equipment automation and associated projects

Qualifications

• Possess strong communication and interpersonal skills

• Demonstrate logical troubleshooting and problem-solving skills

• Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms

• Have the ability to communicate effectively with multiple partners

• Enjoy working in a fast-paced environment

• Demonstrate a collaborative and team-orientated approach

To be considered for this opportunity you should have 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.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), 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 Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), 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 Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.