Manager, Quality Assurance *PC 585

Your Tasks:

This position is primarily responsible for establishing and managing MBI's Quality Assurance system with respect to written Standard Operating Procedures, as well audits to ensure GMP manufacturing activities are compliant with regional, as well as internal requirements by performing the following duties.

Essential Duties and Responsibilities:

• Manage GMP training program, GMP subsystems such as Good Record Keeping practices and maintains training records for MBI.
• Manage Quality Event programs such as Deviations, Investigations, CAPA, Complaints, etc.
• Conduct Batch Disposition which includes reviews such as: Batch Records, QC test result and associated Quality Events.
• Coordinate and host client and regulatory authority inspections, as required.
• Participate in a lead role in internal and external quality audits, including the timely preparation of audit reports.
• Prepare/assess quality audit findings with respect to required corrective actions, ensures timely reporting to Senior Management team and conducts follow-up.
• Develop and manage MBI's document control, product inventory management, final product release, training programs, data trending and metrics.
• Review and approval of Quality Events such as OOL, OOS, CAPA, Investigation, etc.
• Manage the day-to-day Quality Assurance system to include writing, review and approval of Standard Operating Procedures and business practices.
• Manage Quality Records program including archival facilities.
• Perform Quality Assurance review of regulatory submission documents in support of submissions to regulatory authorities, as required.
• Manage and coach Quality Assurance and Compliance personnel.

Requirements:

• Bachelor's Degree in the life sciences with four to six years' experience, master's degree in the life sciences with two to four years' experience; Knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of CGT/ biopharmaceutical products; or equivalent combination of education and experience.
• Experience in quality compliance review and document management a plus. Excellent oral and written communication.

Skills:

• To successfully perform this job, an individual should have knowledge of QMS software such as MasterControl and be proficient in using Microsoft Office and SAP.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

The anticipated base salary range has been established at $119,200 - $161,300/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.