Manager, Process & Personnel Qualification Management Expert

Biopharma Asia; High Wycombe; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Johnson & Johnson in High Wycombe, UK seeks a Manager, Process & Personnel Qualification Management Expert to drive compliance and quality excellence in the pharmaceutical field.

You will lead process improvements, qualification management, and training initiatives, partnering with IM OCMO and governance bodies to ensure the GxP framework adapts to changes in business and regulation, delivering timely project outcomes.

Qualifications

• Strong English communication, both written and verbal.
• Proven ability to manage complex projects with cross-functional teams.
• Analytical thinking and attention to detail in process evaluation.
• Proven leadership, relationship-building, and inclusive teamwork.
• Knowledge of global regulatory requirements in life sciences and pharmacovigilance.

Responsibilities

• Lead PV process and training projects, including development, mapping, and delivery of training/qualification.
• Serve as quality partner for IM Office of the Chief Medical Officer (IM OCMO), connecting business partners with governance and quality groups.
• Manage tasks, timelines and deliverables; identify risks and provide updates to management and stakeholders.
• Support implementation of the digital transformation roadmap toward data-centric content and qualification management.
• May lead or participate in additional projects, audits/inspections, and related activities as needed.

Skills

Communication Skills

Project Management

Analytical Skills

Leadership & Networking

Regulatory Knowledge

Education

Bachelor’s degree in Science or Business

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium R-109382, Switzerland R-109383, United Kingdom R-109384, United States of America R-107418

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

We are searching for the best talent for a Manager, Process & Personnel Qualification Management Expert.

Join Johnson & Johnson's Process & Data Management Team!

Are you eager to learn, collaborate, and make a positive impact? As a Manager in Process & Personnel Qualification Management, you will drive compliance and quality excellence in the pharmaceutical industry.

Purpose:

In this role, you will lead process improvement projects and use the latest digital tools to support the transformation from traditional processes and training into a data centric content and qualification management system.

You will be responsible for:

You will lead Pharmacovigilance (PV) process and training related projects, including process development, mapping, and training development/qualification and delivery.

You will be a vital quality partner for Innovative Medicines Office of the Chief Medical Officer (IM OCMO), promoting collaboration and serving as a link between business partners, quality groups, and governance. This role ensures that our GxP Quality Framework effectively adapts to both business and regulatory changes in a proactive manner.

Your ability to manage tasks, timelines, and deliverables will be crucial for achieving successful project outcomes. Additionally, you will address issues, manage risks, and provide timely updates to management and business owners regarding project progress.

You will support the implementation of our digital transformation roadmap, driving our evolution towards data-centric content and a robust qualification management system.

You may support or lead additional projects, meetings, audits/inspections, etc. as directed.

Qualifications/Requirements:

• Education: At a minimum a Bachelor’s degree in Science or Business is required (Masters degree is preferred).
• Experience: A minimum of 5 years in a medium to large-scale matrix organization, with at least 5 years focused on pharmaceutical/device compliance. Preferred experience includes process design and training design.
• Communication Skills: Exceptional proficiency in both oral and written English communication, with a talent for articulating complex ideas in a clear and effective manner.
• Regulatory Knowledge: Understanding of global (pre)clinical safety and pharmacovigilance compliance regulations and guidelines, coupled with experience in the life sciences industry's regulatory framework.
• Project Management Skills: Demonstrated expertise in managing intricate projects and fostering collaboration among diverse teams and departments.
• Analytical Skills: Keen attention to detail and robust analytical thinking abilities to evaluate business processes and implement improvements.
• Leadership and Networking: Established track record in personal leadership, building relationships, working autonomously, and cultivating an inclusive work atmosphere that values diversity.

Preferred Skills:

• Business Process Management (BPM), Business Requirements Analysis, Coaching, Compliance Management, Cross-Functional Collaboration, Fact-Based Decision Making, ISO 9001, Process Governance, Process Improvements, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Stakeholder Engagement, Standard Operating Procedure (SOP), Tactical Thinking