Combination Products and Medical Devices QA Lead

The Associate Director is responsible for leading Quality for Combination Products and Medical Devices (CP/MD QA) global department that supports design, development, manufacture and regulatory approval of CSL combination products, which include medical device constituent part(s) as well as the audit program to evaluate quality.

This role is accountable for the development, execution, and performance of the Global CP/MD Quality System for combination products in compliance with applicable regulations. The Quality System under the leadership of this role must define / govern quality related business processes throughout the entire combination product lifecycle, with the emphasis on the new product development activities.

The Associate Director is expected to take part in defining the overall company strategy for the combination products, as well as the strategy for the CSL Global Quality.

Reports To: Head, R&D Quality

Direct Reports: Regional Quality Engineer Combination Products and Medical Devices

Responsibilities And Accountabilities

1. Develop, implement and manage Global CP/MD Quality System compliant with the relevant regulations, such as 21 CFR Part 4, applicable chapters of 21 CFR Part 820, MDD/MDR, as well as applicable standards (e.g. ISO 13485). The Quality System must define quality related activities throughout the entire combination product lifecycle from the product concept through commercialization, with the emphasis on the new product development activities for all CSL Behring combination products. Processes governed by CP/MD Quality System must include but are not limited to: Design Controls for the combination products (including risk management); CP/MD vendor management; post-market surveillance and quality reviews.

2. Direct appropriate budget and resource management within CP/MD QA by strategic assessment of workload, required planning for staffing, coordination of consultant activities as needed and on-going review of forecasted expenditures. Ensure appropriate allocation and utilization ofGlobal CP/MD QA resources. Develop, train and mentor CP/MD Quality staff.

3. Provide QA oversight of all R&D/Technical Development projects related to combination products by:

• Developing and implementing Design Control process, as a part of CP/MD Quality System, in compliance with the requirements of 21 CFR Part 820.30, ISO 13485, MDD/MDR and other relevant regulations, as well as applicable standards (e.g. ISO 14971, IEC 62366-1). Design Control processes must incorporate appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.
• Assigning resources to on-going R&D/Technical Development CP/MD projects to ensure that design development work is compliant with the applicable regulatory requirements and follows the Design Controls process. CP/MD oversight is provided for the internal design development activities, as well as custom / novel medical device development conducted by qualified vendors.
  
  
  

4. Ensure processes are in place for a continuous quality oversight of all active CP/MD vendors and service providers. Support Vendor Management activities applicable to CSL Behring medical device development and manufacturing vendors / service providers. These activities include the management of the vendor qualification process, conducting audits; developing and approving quality or development agreements; monitoring vendor performance.

5. Ensure consistent application of the Global CP/MD Quality System processes across the multiple global functions and manufacturing sites by:

• Developing and implementing of CP/MD QA internal auditing program
• Ensuring adequate level of training on the CP/MD QA processes across impacted functions by developing and delivering training courses (e.g. Design Controls, Risk Management, etc.)
  
  
  

6. Proactively monitor changing regulatory requirements for the medical devices and combination products and implement changes to the CSL Behring Quality System, as necessary to ensure compliance. Provide guidance and serve as a subject matter expert on medical device and combination product requirements in accordance with FDA, MDR and other regulations, ISO and other applicable standards, as well as the industry best practices.

7. Inform management regarding CP/MD Quality processes and R&D/Technical Development projects status by providing input and KPIs to the periodic reports. Effectively communicate and escalate potential risks to Quality management and stakeholders.

• Take Part In Strategic Initiatives, As The Following
• Play an active role in defining the overall company strategy for the combination products and Connected Health including: integration of the CP/MD requirements into existing CSL Behring processes and functional structure, development of comprehensive combination products portfolio including platform solutions; proactive assessment of changing regulatory requirements and timely implementation.
• Contribute ideas to the larger strategic vision of Global Quality (including R&D QA) andinteract with the respective Leadership Team to ensure continuous alignment on vision.
  
  
  

9. Lead, participate or provide input to other cross-functional initiatives related to the combination products. Examples may include incorporating combination product requirements into the existing company-wide QMS processes (e.g. post market safety reporting, post market surveillance, recalls management, CAPA process, Risk Management, etc.)

10. Participate in the R&D QA Leadership team, contributing to town hall content, department metrics, executive level status reports and encouraging/driving a quality culture.

Education

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

required to perform the job.)

Bachelor’s degree in relevant engineering or life science discipline.

Experience

• Minimum of 10 years of experience as a quality, engineering or manufacturing professional in medical devices or combination products industry. May consider candidates with pharmaceutical, biotech or other related background.
• Progressively more responsible positions in a complex organization and experience working in a regulated environment.
• Minimum of 2 years of experience in people management, including leading, developing and managing on-site and remote employees.
• Experience in managing multi-site locations preferred.
• Experience in budgeting and financial management preferred.
  
  
  

Competencies

• Strong leadership role with experience in medical device and/or combination product field and working knowledge of the international and national regulations, at minimum, 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDD / MDR, relevant FDA guidances, industry standards and their application in a compliant QMS.
• Extensive practical experience in medical devices R&D Quality: new product development life cycle, design controls, requirement specifications, risk management (including FMEA), validation / verification (V&V), usability / humanfactor studies, DHFs, DMRs.
• Experience in the development, implementation and oversight of Quality Systems.
• Excellent oral and written communication skills, ability to communicate effectively to all levels of the business.
• Strong collaboration, influencing and negotiation skills to allow working effectively across a matrix organization.
• Excellent critical reasoning, decision-making and problem solving skills to analyze complex circumstances, determine risks, and drive appropriate decisions and actions.
• Demonstrated strategic thinking, planning capabilities and organization skills.
• Experience of working in global cross-functional teams.
• Proficient in English and standard MS Office applications.
  
  
  

Travel Requirements

• This role requires periodic domestic and international travel.
  
  
  

The expected base salary range for this position at hiring is $196,000- $232,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.