Job Title: Head, R&D Quality

Job Location: King of Prussia

Number of Positions/Incumbents: 1

Job Family Group: Quality

Job Family: Quality > Quality Multi Discipline

Business/Functional Unit: CSL Behring/R&D Quality

FLSA Status (US only): Exempt

Date: 06/2024

Level: 11

Job Purpose

State the high-level impact and most important job aspects. The purpose should be concise and differentiate this role from others (2 – 3 sentences).

The purpose of the position of Executive Director R&D Quality is to lead a dedicated team responsible for quality oversight for the entire R&D organisation through use of the quality management system and associated processes.

This role is responsible for ensuring that the R&D Quality Policies and Processes are appropriate for the phase of R&D development and comply with corresponding regulations and guidance. There will also be an alignment to an enterprise approach for application of the QMS within R&D.

Responsibilities cover the entire R&D GxP spectrum – GLP, GCP, GCLP, GVP and GMP as well as medical device and combination products regulations. Quality oversight is provided for toxicology studies, clinical development, clinical supply manufacture and packaging and medical device development. Quality oversight and management systems for Pharmacovigilance is also given.

The role is responsible for the leadership and co-ordination of all regulatory GxP inspections for the R&D teams and across development programs, including new commercial product introductions.

RESPONSIBILITIES AND ACCOUNTABILITIES

List the essential job duties and responsibilities in order of priority or time spent on each. Include only those items that are the sole or primary reason the job exists, items that require specialized skills or training, and items that demand a significant portion of time to perform (Do not list competencies, education, training requirements, etc.).

1- To establish and maintain a set of clearly documented quality systems, standards and procedures defining the requirements for each stage of new and lifecycle development products and to advise on the application of these requirements, as needed.

2- Provide direction and oversight of the execution of the QMS specifically for Clinical and Combination Products/Medical Devices, Pharmacovigilance and Safety. Responsible for the execution of the global audit program for R&D, including internal systems and external vendors.

3- To lead and co-ordinate all internal and Health Authority inspections with the appropriate R&D teams. Leadership of inspection readiness plans and action plans post-inspection.

4- Accountable for Quality interfaces end to end in the development process from early phase research to GMP manufacture and commercial launch. Interface with other disciplines including Global Regulatory Affairs, Project Management, Operations and Commercial Operations as to ensure effective QMS transition between R&D and Commercial processes.

5- Chair the senior R&D Quality Management Review designed to ensure visibility and governance for the performance and improvement of the QMS to R&D leadership. Ensure Quality Management Reviews occur within the R&D GxP functions and issues are escalated to the senior R&D Quality Management Review.

6- To define and manage the process for Quality supplier qualification of vendors contracted by R&D, from service providers to CROs/CMOs, inclusive of a routine quality governance as described in Quality Agreements, as

CSL Behring LLC will provide equal employment opportunity for all persons without regard to race, color, religion, national origin, ancestry, age, sex, gender,

pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status or other classification

protected by applicable federal, state or local law. CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business.

applicable.

7- To participate and contribute to key R&D Governance bodies, including the Global Safety Committee.

8- To take an active role in educating R&D and R&D Project Management resources as to the quality requirements across the product development lifecycle.

REPORTING RELATIONSHIP

List jobs that report into this role and to whom this job reports. Include the count of employees directly reporting to this role, including any that report through lower level managers.

Reports To: Global Head of Quality

Direct Reports: 10

JOB SPECIFICATIONS

Provide minimum hiring requirements, specialized knowledge, and other considerations required. In addition, you may include preferred credentials.

Education

(Minimum education required for the role. This includes degrees, licenses, and certifications that are required to perform the job.)

• Requires a degree in a scientific, engineering or related discipline. Post graduate qualifications (Masters/PhD) are preferred.

Experience

(Minimum years of experience and knowledge required to perform the job.)

• Requires minimum of 10 years of experience with equal exposure to both R&D and Quality in R&D. Quality experience should include audit participation at some level.

• Understanding of R&D clinical operations, clinical supply and Pharmacovigilance is essential.

• Experience of GMP Quality is also valuable.

• Knowledge and experience of leading Health Authority inspections.

• Must be comfortable working in a global, matrix organization with cross-cultural experience.

• Experienced at communicating and influencing at senior and executive management level.

Competencies

(Measurable or observable skills, abilities, and behaviors critical to successful

job performance.) Proven leadership, organizational and interpersonal skills by demonstrating the following

competencies at the executive level:

• Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom experience, and judgment; most his /her solution and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

• Innovation Management: Is good at bringing the creative ideas of others to market; has good judgment about which creative ideas and suggestions will work; has a sense about managing the creative process of others; can facilitate effective brainstorming; can project how potential ideas may play out in the marketplace.

• Interpersonal Savvy: Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

• Managing Vision and Purpose: Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision sharable by everyone; can inspire and motivate entire units or organizations.

• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvement in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.

Working Conditions

(Physical & mental requirements.)

• Able to lift up to 15lbs.

Travel Requirements

(Domestic, International, frequency)

• 30% Domestic and International Travel

CSL Behring LLC will provide equal employment opportunity for all persons without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status or other classification protected by applicable federal, state or local law. CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business.

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring (https://www.cslbehring.com/our-company) .

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.

Do work that matters at CSL Behring!

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement