The Opportunity:

The Quality Assurance Manager (Manufacturing) is responsible for oversight of quality assurance activities related to the business operations units, as defined by the quality management system, applicable FDA regulations, ISO requirements, current and future certifications / accreditations and Management.

The QA Manager will provide support and guidance to Quality Assurance associates. Advises Management on necessary continuous improvement efforts so that systems and processes are in line with overall company strategy, voice of the customer, regulatory standards, guidelines and quality policy. Strategically provides technical input and advises / implements necessary process and documentation changes and makes decisions based on customer, associate and company best interests.

This is an onsite position at our Phillipsburg, NJ site.

What we're looking for

• Education: Bachelor’s Degree in a life science discipline, or an equivalent combination of education and experience preferred; formal training and/or advanced courses are preferred

• Experience: 5+ years progressive work experience in Quality Systems, combined with a demonstrated record of accomplishments as a Quality professional, and with strong customer orientation in a similar industry; previous supervisory experience preferred

• Must be familiar with relevant regulations

• Strong knowledge of FDA and international Quality System rules and regulations

• Strong oral and written communication skills

• Strong interpersonal and organizational skills

• Ability to take initiative, maintain confidentiality, meet deadlines, and lead people in a team environment essential

• PC skills required (MS Word, Excel, PowerPoint, Access)

How you will thrive and create an impact

• Manages and provides direction to Quality Assurance department and associates.

• Trains, motivates, monitors and evaluates performance of Quality Assurance associates.

• Direct CAPA program for business operations units (currently knows as NCR) are performing effectively and timely.

• Conduct internal audits for Quality Management System

• Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.

• Have working knowledge of and support compliance with IPEC and FDA Quality System Regulations (QSR); Maintain the integration of FDA regulations, and any other regulatory bodies, into the Quality Management System (QMS). 

• Provide strategic insight to senior management.

• Conduct root cause analysis throughout the Manufacturing group.

• Ensure organizational QMS training is in place; provide training as requested. 

• Lead Complaint Investigation efforts. 

• Maintain and manage cGMP at defined levels of compliance.

• Ensure work product and technical reports provide clarity and accuracy.

• Work directly with customers and suppliers to understand and communicate critical features, requirements and corrective actions, as well as supplier approvals and performance.

• Coordinates objectives with production procedures in cooperation with other managers to maximize product reliability and minimize costs.

• Ensures inspection activity for product throughout production cycle.

• Performs other duties as assigned.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

Privacy Policy:

We will use the personal information that you have submitted to us in order to consider your application for the relevant role.
 

Your privacy is important to us. Please click here for our Privacy Policy which explains the purposes for which we will use your personal information and the ways in which we will handle and retain your information. It also explains the rights you have in relation to your information, and how to contact us with any queries or requests.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Avantor offers a comprehensive benefits package including medical, dental, and vision coverage, wellness programs, health savings and flexible spending accounts, a 401(k) plan with company match, and an employee stock purchase program. Employees also receive 11 paid holidays, accrue 18 PTO days annually, are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.