Supervisor, Front Line Quality Assurance (Fill Finish Expansion)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Sep 10, 2020
Ref
R-121779
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~ 22,000 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 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!

Job Description

Job Purpose:

This Supervisor will be a member of the Front Line Quality Assurance team responsible for Quality Assurance oversight of the Holly Springs Fill Finish Expansion (FFE) project. They will lead a team of QA Specialists that provides strategic and technical expertise for the US FCC expanded Fill Finish facility with full GMP compliance to both US and EU regulations.

The Fill Finish Expansion (FFE) Project is a $140-million expansion of Seqirus' Holly Springs, NC, manufacturing facility. The expansion allows Seqirus to increase capacity for formulation, fill, and finish manufacturing of cell-based and adjuvanted influenza vaccines for global markets and will create around 100 permanent highly skilled jobs, adding to the current workforce at the site of more than 600 employees.

This individual is responsible for the collaborative oversight of activities including Quality Assurance oversight to ensure the facility is built and released according to GMP regulations and procedures. They are responsible for working collaboratively with all relevant departments on operational readiness activities needed to ensure that the Expansion is GMP ready.

They will be the supervisor of Quality Assurance professionals that provide on the floor support to manufacturing, laboratories, utilities, maintenance, and logistics in support of the delivery of the FFE project. Provides technical support for the US Holly Springs site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, regulatory requirements, the Quality Manual, and site SOPs. Supervises the activities and development of direct reports.

The schedule for this role is Monday-Friday; standard business hours; however, some extended and off hours work may be required during specific phases of the project.

Upon the completion of the Fill Finish Expansion project this role will transition to a Front Line QA Supervisor role coinciding with the movement of quality support for the new facility into the FLQA team. The Supervisor will join a team that provides quality oversight of routine operations following an established shift schedule.

Area of responsibility for the position may change over time.

Major Responsibilities:
  • Supervise a staff of QA Specialists (exempt level professional employees) including daily prioritization/workload allocation, coaching/mentoring on issue resolution, and employee performance management.
  • Lead the QA oversight for the Fill Finish Expansion Project as the single Quality Assurance Point of Contact for this critical project valued at $149 million.
  • Ensures that all aspects of the project comply with the requirements of the Seqirus Quality Policies and meets all relevant cGMP regulatory requirements. Monitor and aid in the implementation of project activities to ensure that they are implemented in compliance with GMP.
  • Ensures adequate communication and teamwork
  • Work with cross functional leads of the project to establish recommended QA oversight and guidelines.
  • Provide a link between the Fill Finish Expansion Project and the other QA departments on site.
  • Create and present project highlights to QA team and stakeholders as necessary.
  • Respond to routine quality queries from other departments in relation to the project.
  • Conduct QA activities for the project including review/approval of all project documentation.
  • Strategize with Engineering and Front Line QA management to ensure the expansion areas and the plant have consistent policies and procedures.
  • Direct the creation and/or revision of QA policies/SOPs associated with GMP activities to ensure the documents are compliant with applicable regulations.
  • Support the change control and deviation/corrective action programs as it relates to the Fill Finish Expansion Project as needed.
  • Responsbile for the up staffing of the team to support the FFE commercial readiness as a 24/7 facility. Responsibilities will include recruiting, onboarding and training of said staff.
  • Ensure proper staffing, training, and development of team to support 24/7 operations.
  • Responsible with working with the existing FLQA team to integrate the Expansion team into the existing commercial FLQA team. This would include cross training of the teams to support Bldg 04 and Bldg 05 commercial campaigns.
  • Apply knowledge of regulatory requirements for pharmaceutical, biotech and vaccine industries.
  • Ensures effective professional development of direct reports, through combination of coaching, mentoring and development planning


As needed to support team workload, performs the following FLQA core tasks:
  • Perform real time batch record/logbook review concurrent with manufacturing operations on the manufacturing floor.
  • Perform routine quality walkthroughs in manufacturing.
  • Support quality systems related to QA for in-process sampling and controls and all aspects of FLQA.
  • Act as quality representative on the floor during manufacturing operations and troubleshooting.
  • Provide quality oversight of site critical alarm reports and corrective maintenance program.
  • Support the development and revision of SOPs and batch records.
  • Perform activities related to change controls, writing deviations and investigations, and using electronic enterprise systems Trackwise, SAP, LIMS, etc.


Minimum Requirements:
  • Bachelor's degree in related engineering or scientific field strongly preferred.
  • 5+ years' relevant experience within the biopharmaceutical industry with experience in biotechnology and aseptic processing
  • Demonstrated knowledge of GMPs and FDA requirements
  • Previous experience directly supporting MFG and/or MFG experience in Aseptic Filling/Inspection/Packaging operations with technical understanding of the production processes used in the pharmaceutical or biotechnology industry is required.


Strongly Preferred:
  • 2+ years Quality Assurance experience in a FDA regulated environment
  • 2+ years of supervisory experience or demonstrated leadership role
  • Experience in the delivery of a new GMP facility, i.e. delivery of requirement, acceptance testing, qualification, and validation
  • Strong technical understanding of the production processes used in the pharmaceutical/biotechnology industry