Head, Site Compliance (Holly Springs)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Sep 25, 2020
Ref
R-121685
Required Education
Bachelors Degree
Position Type
Full time
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 Summary:

The Head of Site Compliance role will assure that site and related functions are in compliance with GxP regulations, including, but not limited to, cGMPs, cGLPs for the markets in which Seqirus operates. The individual will organize and promote site quality and compliance improvement efforts. Working closely with other Heads of Site Compliance and the Global Head of Quality Systems and Head of Site QA to focus on areas of strategic importance.

This will include site adherence to existing site and global policies and procedures, introduction of new regulatory compliance requirements, identification of trends from KPIs / quality reviews and implementation of initiatives to exceed quality targets

The Head of Site Compliance promotes and influences site compliance and the broader Quality Culture. The role is critical in supporting the operating model that ensures quality product supply and license to operate. It requires an individual that has extensive pharmaceutical quality operations experience including experience with regulatory requirements.

This position will lead cGMP Compliance initiatives, maintain knowledge of and implement, current cGMP regulations and industry best practices for associated Quality Systems. The position will support regulatory filings and regulatory agency reporting, and the implementation of compliance site initiatives and procedures.

Reporting to the Head of Global Quality Systems and Compliance with accountability to the Site Head of Quality.

The incumbent will be an integral member of the Global Quality Systems and Compliance Leadership group.

Major Accountabilities:

Regulatory GxP compliance
  • Support Regulatory Inspections (pre and post inspection) external engaging with all site functions
  • Provides support for the analysis of Inspection Results and response to authorities is timely and commitments are delivered on time
  • Partners with the Audit management team to ensure regulatory commitments are consistent with / have agreement by all Seqirus sites
  • In conjunction with the site Audit team will track regulatory findings and trends that may lead into a focus of regulatory inspections


Internal process compliance
  • Ensure Site BDPR / Regulatory Notification Processes are in place, personnel are trained, and systems followed
  • Track of BPDR commitments and follow up actions
  • Ensures maintenance of Site Master File
  • In conjunction with the Audit Management team will Track site-based Self / QA Inspections are completed to schedule and tracking internal audit findings and ensuring completion of corrective actions
  • Responsible for the Regulatory Intelligence Process
  • Tracking of PQR/APQR adherence to schedule and completion


Site compliance monitoring and improvement
  • Participation and Management of Global and site Quality Council
  • Management of site Metrics/KPIs definition and delivery to key stakeholders
  • Delivery of GMP compliance component of new employee induction and maintenance of course content
  • Responsible for the coordination, verification and tracking of compliance improvement activities with a view to driving down out of compliance events. Working with the wider site functions.
  • Develop / support strategic quality compliance in all areas of the site
  • Facilitate mitigations of identified site quality risks from Quality Risk Management processes
  • Researches relevant regulations, quality systems and business processes to identify mutually agreeable technical options that comply with regulations.
  • Responsible for identification of new GxP trends and development of strategies to fulfil new expectations
  • Manages annual plans for areas of responsibility in collaboration with internal stakeholders.
  • Acts Single Point of Contact to QA site heads to facilitate communication and resolve issues. Takes incoming communications and directs them to the right internal staff within the systems teams on site creating a consistent approach driving clear and efficient communication.

Minimum Qualifications:

  • Bachelor's degree or equivalent education in a related scientific, business, process/industrial engineering major.
  • Requires a minimum of 7 years' experience within pharmaceutical quality systems / quality assurance, 10+ years relevant experience preferred
  • Strong knowledge of GxPs, FDA, EMEA, and TGA Regulations governing validated applications including 21CFR Part 11
  • Strong knowledge of GxP regulations / industry expectations for Quality Management System processes and associated systems.
  • Understanding of IT applications and development processes per International Standards (e.g. GAMP5).
  • Demonstrated ability to lead highly productive teams who are driven to optimize processes.
  • Demonstrated ability to think strategically and to work collaboratively using risk-based, proactive approaches to operations problem-solving
  • Excellent analytical, written and oral communication skills for both strategic and tactical messages
  • Technical knowledge of the following technologies is desirable: TrackWise, Success Factors, Documentum, SAP