CQA Regional Lead (The Americas)

Employer
CSL Behring
Location
Cambridge, Massachusetts
Posted
Nov 05, 2020
Ref
R-123455
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

This is a regional position (with responsibility for The Americas including Latin America); responsible for liaison and interface with customer groups and Global CQA in order to drive systematic quality improvements and to ensure

compliance with applicable international regulations, guidelines and global company standards.

This role is key to providing proactive quality management to support clinical development activities across R&D. The position is also responsible for regional oversight of the planning and implementation of the Global CQA Audit Program, including Health Authority inspection preparation and management.

This position may have direct reports or be responsible for managing

contracted Auditor resource and will be responsible for management

and performance of these reports and/or contractors.

Responsibilities include: -

Acts as the primary point of contact with clinical development and

clinical operations teams to provide GCP and process related guidance

and support; works with teams to investigate and resolve clinical study

related GCP compliance, deviations and process related issues,

providing recommendations for solutions and CAPAs as needed.

Includes communication and presentation of summaries of audit findings, trends, KPIs with recommendations to support continuous improvement in study and project activities.

Works closely with other Regional CQA peers and the CQA Systems

and Operations Lead to ensure successful development, execution and

completion of the Global GCP Audit Program.

Responsible for risk assessments, input of information and tracking progress

of projects/studies to be audited in their region of responsibility and/or

for specific allocated projects

Manages Auditor resource including external consultants in support

of the audit program

Ensures consistency in approach and reporting of audits across their

Region.

Evaluates the adequacy and completeness of corrective and preventative

action plans.

Performs audits of investigational sites, CROs/Service Providers, documents and internal system and processes, in order to ensure compliance with

regulatory requirements and company policies and procedures.

Prepares written audit reports and communicates findings and

recommendations. Evaluates the adequacy and completeness of corrective

and preventative action plans.

Manages preparation activities for regulatory inspections in their Region and may support other Regions as needed:

Prepares an inspection readiness plan for allocated projects and conducts

inspection readiness site visits

Communicates results and inspection preparedness to appropriate customer groups. Responsible for inspection readiness training within region/allocated projects Provides support during and follow-up of inspections; may act as the primary Inspection Coordinator for local inspections including direct interaction with inspectors in preparation, during the conduct and follow-up of the

inspection.

Contributes to the larger strategic vision of the CQA department and interacts with the R&D QA Leadership Team to ensure continuous alignment and

improvement within the function. Supports the CQA Systems and Operations Lead to ensure the provision of accurate and timely reports on metrics, findings, and trends stemming from audits, inspections and deviations and proposes and/or implements improvement initiatives, as needed

Supports CQA system and process improvement initiatives; assists in

developing appropriate tools and procedures to further enhance CQA activities

Representation on CQA, R&D QA or Global Quality process/project work-streams

Qualifications, experience and competencies: -

University/College Degree in Scientific discipline/Life Sciences or similar

Minimum 8 10 years' experience in the pharmaceutical industry

Experience in Clinical Operations, Clinical QA and/or GCP auditing

(minimum 5 years)

Demonstrated understanding through prior experience of GCP regulations

and knowledge of international and national regulations and guidelines

related to the conduct of clinical research

Excellent communication and interpersonal skills to build key networks and business relationships across all levels of the business

Proven experience in working across international clinical trial teams;

working in a multidisciplinary environment

Ability to analyse complex issues, problem solve and take appropriate

decisions and actions

Good influencing and negotiation skills

Excellent written and verbal communication

Good PC skills in programs such as Word, Excel and PowerPoint

Experience in a people management role preferred but not essential.

This position requires national and international travel.