Assistant Manager of Quality
Company: CSL Behring
Location: East Providence
Posted on: January 12, 2021
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Job Description:
About CSL With operations in 35 nations and 27,000 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 CSL's therapies. Seqirus
is one of the largest influenza vaccine companies 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 Job Description Job
Description --- 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. --- 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 timely audits. Utilize quality tools and
applications to facilitate understanding of issues and
documentation. --- Maintain clean efficient work environment and
ensure 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 CAPA's and effectiveness checks to ensure issues are
resolved. --- Perform other job-related duties as assigned.
Education --- Bachelor's 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 department's 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. CB Job
Description --- 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 CB
Keywords: CSL Behring, East Providence , Assistant Manager of Quality, Executive , East Providence, Rhode Island
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