Sr. Manager, Quality Control
Xellia

Job Info

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Would you like to join an award winning organization that is dedicated to saving lives?

In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.

Is that you? If so, we want to learn more about you!

Our Bedford, OH facility is seeking a Senior Manager, Quality Control. This individual will lead a multifunctional team comprised of Quality Control Chemistry and Microbiology and Method Transfer personnel.

Key Responsibilities

• Ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards
• Ensure all laboratory documentation meets applicable Current Good Documentation and Data Integrity requirements
• Develop appropriate metrics to monitor quality performance and trends
• Successfully maintain approved budget for direct reporting staff
• Provide oversight for the calibration and maintenance system within the laboratory
• Responsible for the authorization of SOP's and/or qualification/validation documents associated with the laboratory operations
• Participation in Change Control committee
• Participate as a Subject Matter Expert in customer audits and inspections by Regulatory agencies
• Develop and maintain employee development framework for the laboratory personnel
• Ensure that personnel are trained on the relevant procedures
• Support of stability programs for marketed products
• Surveillance of information with the technical/scientific fields of interest of the department, including requirements set by government agencies and GMP trends.
• Perform additional tasks in relation to quality issues
• Manage and escalate Quality issues to the VP of Quality NA and relevant Xellia Leadership Team members
• Ensure processes and products comply with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality
  Ensure knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies

Requirements

• B.S. in Microbiology, Chemistry, or equivalent science discipline
• Minimum of 5 years of management experience overseeing laboratories, with a minimum of 8 years of experience in an FDA Regulated industry
• Significant experience supporting an aseptic operations facility, proficient in microbiology
• A proficient knowledge of various GMP/GLP compliances regulations and industry practices
• Ability to critically evaluate and troubleshoot complex problems is essential
• Strong hands on leadership and management skills with a can do attitude
• Ability to effectively participate and lead multi-disciplinary teams
• Ability to absorb, digest and relate detailed scientific, quality, and regulatory information
• Well-organized and detailed oriented professional, with strong verbal and written communication skills

Physical Requirements of the Role

Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally.

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.

With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.

Further information about Xellia can be found at: www.xellia.com
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