Quality Deployment Lead (Remote Short-Term Assignment)

Employer
CSL Behring
Location
Working from home
Posted
Sep 25, 2021
Ref
R-148574
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

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

1 Responsible for maintaining quality oversight of implementation activities including but not limited to execution of implementation checklist action items, equipment management, supply management, document management and training. Troubleshooting implementation exceptions and making necessary adjustments to ensure an efficient and effective project implementation in plasma centers.

2  Provide quality compliance oversight of deployment team members and plasma centers involved in the implementation. Identify and manage issues of non-conformity including implementing containment and remedial actions, implementing corrective actions, ensuring appropriate documentation of non-conformance and determining effectiveness of these actions. Responsible for notification to the Assistant Manager of Quality Assurance, Innovation or Associate Director Operations and Quality, Innovation 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 may be elevated to any of the following, project leadership, Associate Director of QA, or Director Quality Assurance.

3  Monitor, track, and trend implementation activities to meet established milestones and deadlines. Makes decisions to resolve issues that may jeopardize the implementation process. Monitor, track and trend quality metrics for implementation. Provide reports and status updates on implementation progress and quality compliance to include metric and KPI information to manager, project team members, and project leadership.

4  Monitor implementation training and training assignments through the use of Plateau reports and/or other Plateau admin items. Support training of deployment team members and plasma center employees.

5  Support plasma center audits and inspections as related to project implementation activities by responding to inquiries and providing reports or attending inspections as requested.

6  Provide oversight of employee relation issues and will collaborate with Assistant Manager of Quality Assurance, Innovation. Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicates effectively with HR to ensure HR compliance.

7  Act as a liaison within a multi-layered project by transferring knowledge and sharing communication to other groups as needed. Shares information with external and internal contacts with common desire to reach a solution. Will be responsible for contacting company employees at multiple organizational levels to resolve implementation quality issues and provide implementation readiness updates.

8  Provide a model of good customer service to all employees. Collaborate with center leadership to ensure and provide excellent customer service. Communicate openly with employees and vendors. Effectively resolve complaints or concerns.

9 MTQ’s must be able to complete leadership development program and be able to relocate within 6-7 months of completion of the deployment short term assignment.

10  Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.

11  Follow all Standard Operating Procedures (SOPs), company policies and procedures. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.

12  Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.

13  Maintain confidentiality of all personnel, donor and center information.

14  Perform other job-related duties as assigned.

Education

o   Bachelor’s Degree preferred or equivalent combination or education and professional work experience required

Experience

o   Minimum one (1) year of supervisory leadership experience to include responsibility for overseeing the activities of others

o   One (1) year Quality experience required or completion of CSL Plasma Leadership Development program

o   Must be proficient in Plateau administrative tasks and deviation/error management

o   Ability to interrupt implementation progress and/or status and remain agile to adjust overall objectives

o   Ability to lead staff without direct authority, which includes providing feedback, giving direction, and holding other accountable for actions and results

o   Ability to keep others in remote locations on track to achieve company stated results

o   Must be proficient in Word, Excel, PowerPoint, and email applications

Additional Comments

o   Bilingual skills a plus

o   Requires solid written communication skills in standard business language for composing and editing correspondence

o   Proficient in English language

o   Proficient in MS Office

o   Strong organizational skills motivated and self-starter

o   Able to take initiative and react quickly and with precision to urgent situations

o   Requires working with in restrictive confidential projects to support overall CSL strategy

o   Strong background in document control

o   Strong background in the equipment validation process (including, but not limited to, failed

o   validations)

Working Conditions

(physical & mental requirements)

o   Shares information with external and internal contacts with common desire to reach a solution

o   Ability to make decisions which have significant impact on the department’s creditability, operations, and service

o   Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact and/or develop presentations

o   Occasionally perform tasks while standing and walking up to 100% of the time

o   Reach, bend, kneel and have a high level of manual dexterity

o   Overnight travel required greater than 80% of the time

o   Ability to lift and carry up to 30 lbs.

o   Required to wear Personal Protective Equipment while performing specific tasks to prevent exposure of blood borne pathogens

o   Ability to make decisions which have significant impact on the immediate work unit

o   Attention to detail and ability to follow written and verbal directions required

o   Extended work hours and weekends may be required

o   Fast paced environment with frequent interruptions

Note: 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.

Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. We may have both full-time and part-time positions available. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate.