Manager, Quality Control - Madison, WI | Biospace
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Manager, Quality Control

Catalent Pharma Solutions, Inc.

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Location:
Madison, WI
Posted Date:
5/18/2017
Position Type:
Full time
Job Code:
0021300
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, QC, Quality, Quality Control,

Job Description


Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients globally. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients around the world.

Catalent is seeking a Quality Control Manager for the Madison, Wisconsin site. The Quality Control (QC) team is responsible for testing products, raw materials and the manufacturing environment to ensure the Safety, Quality, Identity, Purity and Potency produced by the Catalent Madison Biologics facility.

This position works to assure that operations at Catalent meet client requirements and cGMP regulations via Quality Control staff. The Manager will ensure responsiveness to clients and overall client satisfaction. Responsible for coordinating and implementing activities to attain strategic objectives within a department and looks to his or her direct supervisor or other peers within the industry for guidance. In addition, the manager is able to establish goals and objectives, supervise work practices for direct reports, interprets and executes policies and procedures that typically affect organizational units. This position will interact with other departments or divisions within Catalent. At the senior level, this position requires extensive independent judgment.

Specific Duties, Activities, and Responsibilities Include:

o   Manages the Quality Control department daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems.
o   Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy.
o   Ensures compliance with current federal, state and local regulations. Consults with Human Resources Department as appropriate.
o   Ensures Quality Control systems are compliant with corporate and site procedures, as well as industry standards.
o   Interacts with customers during meetings and visits; provides responses to customer’s questions.
o   Supports development of novel QC analytical methods.  Works in conjunction with other departments to develop, qualify, and transfer QC analytical methods.
o   Ensures maintenance of QC equipment – qualification, calibration and maintenance.
o   Participates on Validation Team and Project Teams, as applicable.
o   Leads the CAPEX process for QC; including commissioning and qualification of new equipment, instruments, including major capital projects and computer systems.
o   Drafts, reviews, and approves Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation.  This includes deviation investigation and reporting.
o   Manages contractors as required.
o   Develops and implements statistical tools for Quality Systems monitoring and review.
o   Reviews and approves changes to critical processes, facilities, equipment and systems through the change control program to assess impact on validated systems.
o   Assists in customer / regulatory audits and responding to audit observations and corrective actions.
o   Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
o   Collaborates significantly with cross functional groups, including QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
o   Provides technical assistance and training for personnel
o   Files and maintains controlled documents.
o   Other duties as assigned.

About Catalent

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients globally. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients around the world.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.

Our VISION is to be the world’s most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations while driving strong, sustained growth for the company.

Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.

OUR VALUES are at the foundation of everything we do:

•          Patient First:  We put patients at the center of our work to ensure the safety, reliable supply and optimal performance of our products
•          Customer Dedication: We strive to exceed our customers’ expectations every day
•          People: We are committed to the growth, development and engagement of our people
•          Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes
•          Integrity: We demonstrate respect, accountability and honesty in every interaction
•          Excellence: We have a passion for excellence in everything we do.

Requirements


Education:

o   PhD in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum 6 years’ related experience with demonstrated career progression including leadership responsibilities.
o   Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum 8 years’ related experience with demonstrated career progression including leadership responsibilities.
o   Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum 10 years’ related experience with demonstrated career progression including leadership responsibilities.

Experience:

o   Experience with managing people and providing leadership.
o   Thorough knowledge of cGMP regulations related to Quality Control required.  Phase III / Commercial cGMP regulatory knowledge preferred.
o   Experience with analytical methods such as HPLC, SDS-PAGE, cIEF, CE and ELISA required, and Microbiology testing preferred.
o   Experience in aseptic processing including cell culture and protein purification is preferred.
o   Experience in ICH Q7 and 21CFR Parts 210 and 211 preferred
o   Experience in biotech (aseptic processing including cell culture and protein purification) is preferred – clarification of below
o   Proven track record in method validation / qualification and qualification of equipment / systems.
o   Experience with facility / laboratory expansions preferred.
o   Experience in a QC support of a manufacturing setting is preferred.