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20 days old

Quality Assurance - Senior Manager

Kelly Services
Germantown, WI 53022
**Kelly Services is actively recruiting for a Direct Hire opportunity for a Senior Manager of Quality Assurance. This location in Germantown, WI.**


The Senior Manager of Quality Assurance needs to be an adaptable professional accountable for driving team and organizational results in a fast-paced expanding business environment.


Key areas of focus are establishing and maintaining compliant and robust quality systems, leading and driving continuous quality improvement initiatives, leading and coaching a team of quality specialists to ensure on time releases, ensuring the utmost in customer satisfaction, troubleshooting quality events and serving as a subject matter expert in Quality System elements. The position requires superior leadership behaviors of core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.


Essential Functions of the Senior Manager - Quality Assurance includes:


+ Understands and applies GMP principles to the manufacturing and oversight of Active Pharmaceutical Ingredients (API) following global regulations.

+ Works with site management and peers to lead Quality and Compliance.

+ Manages and oversees the daily activities of the Quality Assurance Unit.

+ Tracks and manages unit performance against site metrics.

+ Manages Quality Systems to ensure timely closure of Deviations, Investigations, Corrective Actions, etc.

+ Identifies and implements action plans to mitigate risks and drive continuous improvement.

+ Reviews and approves Standard Operating Procedures, Master Production Records (if necessary) and Specification Test Records.

+ Reviews batch production records.

+ Reviews and approves validation protocols and reports.

+ Collaborates with various departments and facilitates facility and cGMP training as necessary.

+ Serves as a Quality contact for clients.

+ Performs Quality System reviews as required.

+ Communicates compliance concerns to Director/Departmental Managers/President.

+ Proactively works to improve quality systems and enhance overall quality.

+ Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

+ Fosters and develops staff through work assignment and establishing of stretch goals, with a focus on individual growth and planning for future needs of the organization.

+ Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.

+ An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.


Requirements for the Senior Manager - Quality Assurance includes:


+ Bachelors degree in Chemical Engineering or related field.

+ 10+ year of industry related experience, including 3+ years supervisory experience plus either 2+ years of project management or 2+ years of management level experience.

+ Strong knowledge of Quality Systems.

+ Working knowledge of cGMP in a pharmaceutical or regulated environment.

+ Working knowledge of FDA and ICH-Q7.

+ Strong technical writing and critical thinking skills.

+ Excellent verbal and written communication skills.

+ Excellent presentation skills.

+ Directly leads team of approximately 8 - 10 direct reports; and indirectly leads team of approximately 3 - 5.

+ Must be very organized as position has quality oversight for up to 20 customer programs at one time.

+ Involved and participates in Regulatory and Customer Audits.

+ Strong understanding of validation and change control.

+ Participates in the hiring process of other employees.

+ Schedules and reviews the work of other employees.

+ Determines methods and procedures to accomplish business requirements, including new assignments and the work of others.

+ Ensures accuracy and relevance of assigned training curriculum for direct and indirect reports.

+ Drives timely completion of training for direct and indirect employees to meet regulatory requirements.

+ Coaches, mentors and develops other employees.

+ Prepares and delivers performance evaluations of other employees.

+ Makes recommendation of disciplinary actions of other employees.

+ Uses professional concepts and company policies and SOPs to solve a variety of problems.

+ Proficiency with Microsoft Office Software (Word, Excel, PowerPoint).


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-06 Expires: 2022-06-06

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Quality Assurance - Senior Manager

Kelly Services
Germantown, WI 53022

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