NewHavenRecruiter Since 2001
the smart solution for New Haven jobs

Assistant Manager of Quality

Company: CSL Behring
Location: East Providence
Posted on: August 14, 2019

Job Description:

With operations in 35+ nations and - 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSLs therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Responsibilities Ensure center is inspection ready at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center. Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes (e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management. Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination. Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. Working knowledge of the change management process and appropriately raise ideas for consideration for change locally and upward to quality and area management. Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies. Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of audits timely. Utilize quality tools and applications to facilitate understanding of issues and documentation. Maintain clean efficient work environment and ensures sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions. Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same. Comply with all federal, state and local regulatory and company policies and procedures. Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance. Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable. Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPAs and effectiveness checks to ensure issues are resolved. Perform other job-related duties as assigned. Education Bachelors Degree preferred Equivalent combination of education and professional work experience required Experience Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR 1 year Quality experience (CSA/CSAb) required OR Completion of CSL Plasma Leadership Development program Additional Comments Maintain company Technical Training certification Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations Monitor and manage entire financial responsibility of the center Proficient in English Working Conditions (physical & mental requirements) Ability to make decisions which have significant impact on the departments creditability, operations and services Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens Overnight travel required up to 10% of the time Generally spends 80% of the time standing and walking and 20% of time sitting Occasionally lift and carry up to 25 lbs. Exposure to hot and cold temperatures, sudden temperature changes working with freezers and various odors Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc. Required to wear Personal Protective Equipment while performing specific tasks or in certain areas Fast paced environment with frequent interruptions All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Qualifications Bachelor degree in scientific discipline/life sciences or related discipline 5+ years' experience related to quality and regulatory/ Plasma industry experience Demonstrated leadership/supervisory experience Knowledge of government and industry regulations Capabilities Worker Type:Employee Worker Sub Type:Regular

Keywords: CSL Behring, New Haven , Assistant Manager of Quality, Executive , East Providence, Connecticut

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Sales Manager, NL
Description: Would you like to build upon your career in digital sales with the market leader one of the fastest growing companies in online marketing and in an international environment --Outbrain is seeking a highly (more...)
Company: Viola
Location: New York
Posted on: 08/19/2019

Senior Engineering Manager, Support and Trust Safety
Description: Etsy seeks a senior engineering manager to lead our Customer Resolutions engineering team, which supports our customer support, and trust and safety product initiatives. Using tools built and maintained (more...)
Company: Etsy
Location: New York
Posted on: 08/19/2019

Construction Project Manager
Description: Firm BackgroundShorewood Real Estate Group LLC is a multi-strategy real estate investment platform that specializes in the acquisition, financing, and development of institutional quality assets in major (more...)
Company: Shorewood Real Estate Group
Location: New York
Posted on: 08/19/2019


Product Manager - New York
Description: window.curStateVal
Company: Viola
Location: New York
Posted on: 08/19/2019

Project manager/Social Media and Marketing Manager
Description: We are looking for a superb writer to create daily content for multiple platforms, who must be computer savvy and familiar with Google Docs, highly resourceful, and able to balance multiple
Company: Six Floors Inc.
Location: New York
Posted on: 08/19/2019

Data Manager - New York
Description: window.curStateVal
Company: Viola
Location: New York
Posted on: 08/19/2019

Guest Relations Manager
Description: EMPLOYMENT STATUS br br Full-Time br br OVERVIEW br br The Guest Relations Manager is responsible for ensuring the operation of the Guest Services, Concierge and Uniformed Services/Transportation (more...)
Company: Highgate Hotels, LP
Location: New York
Posted on: 08/19/2019

Customer Success Manager - New York
Description: Customer Success Manager - Buenos AiresPayoneer's mission is to empower businesses to--go beyond--- beyond borders, limits and expectations.In today's digital world, Payoneer enables businesses of all (more...)
Company: Viola
Location: New York
Posted on: 08/19/2019

Veterinary Medical Director ($135k+Generous Benefits Package)
Description: The Animal Hospital of Chelsea is seeking a veterinarian to join our team as Medical Director. This is an exciting opportunity to join a well-established general practice and help grow it into a thriving,
Company: Animal Hospital Of Chelsea
Location: New York
Posted on: 08/19/2019

RN Case Manager - Workers Compensation - Urgent Care Clinic
Description: Solid reputation, passionate people and endless opportunities. That's Travelers Our superior financial strength and consistent record of strong operating returns mean security for our customers - and (more...)
Company: Travelers Insurance
Location: Parsippany
Posted on: 08/19/2019

Log In or Create An Account

Get the latest Connecticut jobs by following @recnetCT on Twitter!

New Haven RSS job feeds