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!
The Manager Site Compliance role will report to the Head of Site Compliance. The role will support and ensure that the 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 support and execute site quality and compliance improvements, working closely with relevant stakeholders on site. This position will support cGMP Compliance initiatives and assist the, implementation of current cGMP regulations and industry best practices for associated Quality Systems.
Site compliance monitoring and improvement.
Coordination Global and site Quality Council, including Global Operational and Quality functional reviews and supporting global forums and executed as per schedule.
In conjunction with the Quality Systems team supporting the delivery of Metrics/KPIs to key stakeholders
Working with the wider site functions to drive down out of compliance events and identify any improvements to process.
Identifying GxP trends and communicating to relevant stakeholders
Support the implementation global action plans based on risk in collaboration with the local sites and functions
Ensure course content for GMP compliance component for new employee induction adheres to current regulatory requirements
Monitor and assess the global regulatory environment with the goal of anticipating and communicating regulatory trends through an understanding of regulatory guidelines, regulations and laws that may have an impact on Seqirus manufacturing sites and/or vendors
Manage the review process for new draft guidelines and regulations and develop implementation plans as required
Set up and implement a Regulatory Intelligence (RI) approach to deliver regular RI updates through education, knowledge sharing, newsletters, reports and other modes of communication to advance regulatory expertise and decision making considering all areas of the business
Internal process compliance
Executing the Regulatory Intelligence Process by reviewing/ assessing draft regulations, pharmacopeia update and regulatory guidance documents to determine their potential impact on Seqirus
Interpret new /changing regulations and provide recommendation on how Seqirus aligns with new / changing requirements and if there is an impact or no impact with new / changing regulations.
Support site BDPR / Regulatory Notification Processes by ensuring personnel are trained, and systems followed
In conjunction with Quality Assurance will support tracking of BPDR commitments and follow up actions
In conjunction with the Audit Management team will Track site-based Self / QA Inspections are completed to schedule and track and trend inspection/audit responses and commitments and ensuring completion of corrective actions.
Track key audit performance metrics and participates in periodic reviews to ensure effectiveness of the Quality audit and inspections program.
Supports the tracking of PQR/APQR adherence to schedule and completion
Regulatory GxP compliance
Support Regulatory Inspections (pre and post inspection) – external
Provides support for the analysis of Inspection Results and assist with responses by engaging with all site functions
In conjunction with the site Audit team will support track regulatory findings and trends that may lead into a focus of regulatory inspections
Acts Single Point of Contact between QA site heads and Global Quality System and compliance (GQS&C) team as delegated by Head Of Compliance .
And other job duties that may be assigned from time to time by the Head of Compliance
Knowledge, Skills & Competencies
Sound Knowledge of GxPs, FDA, EMEA, and TGA Regulations governing validated applications including 21CFR Part 11
Sound knowledge of GxP regulations / industry expectations for Quality Management System processes and associated systems.
Excellent interpersonal effectiveness, written/verbal communication, influencing and negotiation skills
Excellent computer skills and strong knowledge of Quality Systems. Direct experience with Microsoft Office including Word and
Excellent organizational skills with respect to planning/ tracking and timelines
Ability to work independently to analyse issues and problem solve to support decision making
Strong technical writing skills in Standard Operating Procedures and Work Instruction
Strategic thinker with the ability to see the big picture, think broadly, evaluate alternatives and recognize the underlying issues
Self-motivator with the ability to follow-up on and complete multiple projects simultaneously.
Highly attentive to details and able to work well as part of a team.
Understanding of potential impact of Regulations/Trends on the business and identify global/local actions.
Minimum Education Requirements
Bachelor’s degree or equivalent education in a related scientific, business, process/industrial engineering major.
Minimum Experience Requirements
Requires a minimum of 5 years’ experience within pharmaceutical quality systems / quality assurance. Must be able to work independently with minimal or no supervision. Must be able to critically interpret results and determine the desirability of new or additional content for GMP policies and standards etc.