Manager, Clinical Program Documentation Control and Audit Readiness

Biogen; Warszawa; Hybride; PLN 166 000 - 228 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Remote work allowance

Annual bonus

Flexible work arrangements

Résumé du poste

Biogen Poland seeks a Manager of Clinical Program Documentation Control and Audit Readiness to coordinate audit readiness, inspection support, and documentation control for CPSC activities. You will own documentation standards, govern SharePoint, and maintain SOPs, templates, and training materials to ensure complete, traceable records for country submissions and regulatory inspections.

You will collaborate with R&D Quality, Legal, Regulatory, and Trial Master File teams to align documentation

Qualifications

• Bachelor’s degree required in Business, Life Sciences, or related field.
• 5+ years in project management, documentation control, procurement, sourcing, or vendor management.
• Experience developing SOPs, work instructions, training materials, and SharePoint governance models.
• Excellent written and verbal communication skills.
• Strong organizational discipline and high attention to detail.
• Ability to influence without direct authority across multiple teams.
• Demonstrated leadership and accountability.

Responsabilités

• Serve as the primary Clinical Procurement contact for audit, inspection, submission, and oversight support.
• Retrieve, review, stage, and package procurement records ensuring complete, traceable documentation.
• Partner with R&D Quality, Internal Audit, Legal, Regulatory, Trial Master File teams to align documentation with audit scopes.
• Develop reusable audit response playbooks, SOPs, templates, and training materials.
• Identify gaps and readiness risks; recommend remediation and drive closure.
• Support cross-functional continuous improvement initiatives to enhance evidence retrieval and inspection readiness.
• Translate regulatory expectations into practical procurement documentation standards and processes.

Connaissances

Project management

Documentation control

Procurement & sourcing

SOPs & training materials

SharePoint governance

Communication

Attention to detail

Leadership

Influence without authority

Formation

Bachelor's degree in Business/Life Sciences or related

Outils

SharePoint

Description du poste

About This Role:

As Manager of Clinical Program Documentation Control and Audit Readiness, you will play a pivotal role in coordinating audit readiness, inspection support, documentation control, and evidence response specifically for CPSC (clinical sourcing and contracting) activities. You will ensure that procurement records are meticulously complete, traceable, consistently stored, and readily retrievable for country submissions, vendor audits, internal audits, quality reviews, and regulatory inspections. The role involves owning CPSC documentation standards, governing SharePoint, and maintaining SOPs, templates, training materials, and reusable inspection-readiness processes. You will represent CPSC in key systems, standards, policy, and continuous improvement initiatives to strengthen documentation quality and promote sustainable ways of working. This position is integral to the business, ensuring that documentation practices are robust and compliant, thus safeguarding our operational integrity and facilitating seamless audit processes.

What You’ll Do:

• Serve as the primary Clinical Procurement point of contact for audit, inspection, submission, and oversight support, including intake, triage, tracking, status reporting, escalation, and timely response management for procurement-related requests.
• Retrieve, review, stage, and package procurement records, including contracts and related files, ensuring documentation is complete, traceable, consistently stored, and inspection ready.
• Partner with R&D Quality, Internal Audit, Legal, Regulatory, Trial Master File teams, Vendor Management and Clinical Study Teams to align procurement documentation and audit responses with audit scopes, GCP sponsor inspection needs, and regulatory expectations.
• Develop reusable audit response playbooks, controlled documentation practices, file governance models, audit trackers, SOPs, templates, and related training materials to support consistent, sustainable ways of working.
• Identify documentation gaps, process issues, and readiness risks; recommend remediation steps, and drive closure.
• Support and represent CPSC in cross-functional continuous improvement initiatives, including Vendor Management Hub and Trial Master File processes, that enhance evidence retrieval and strengthen inspection readiness.
• Translate quality, regulatory, and enterprise process expectations into practical procurement documentation standards and processes while managing continuous improvement efforts, including coordinating process simplification, integration support, and training activities, implementation plans, stakeholder engagement, and cross-functional working groups to standardize processes.

Who You Are

You are an organized and detail-oriented individual who thrives in managing complex documentation and audit processes. Your ability to influence without direct authority and coordinate effectively across diverse teams sets you apart. You are adept at translating regulatory expectations into clear procurement actions and have a knack for developing sustainable processes. Your leadership skills enable you to guide cross-functional stakeholders through ambiguity and keep them aligned. You possess a natural ability to motivate and facilitate decision-making among teams, ensuring a streamlined approach to documentation and audit readiness.

Required Skills:

• Bachelor’s degree required (Business, Life Sciences, or related field).
• 5+ years of professional experience in project management, documentation control, procurement, sourcing, or vendor management.
• Strong project management capability, including intake tracking, milestone management, and risk identification.
• Experience developing SOPs, work instructions, training materials, and SharePoint-based documentation governance models.
• Excellent written and verbal communication skills.
• Strong organizational discipline and high attention to detail.
• Ability to influence without direct authority and coordinate effectively across multiple teams.
• Demonstrated leadership skills, including the ability to set direction and drive accountability.

Preferred Skills:

• Working understanding of regulated clinical development environments and inspection-ready documentation.
• Experience supporting audits, inspections, quality reviews, and regulatory submissions in biotech/pharma settings.
• Experience leading continuous improvement initiatives or operational excellence projects.
• Lean Six Sigma training or certification, such as Green Belt, or demonstrated use of Lean problem-solving tools.

Additional Employment Conditions

• This role requires occasional flexibility in working hours from 12:00 to 20:00 CET. Such flexibility is expected to be one full working week per month and likely closer to one working week per quarter. This is to support global business coverage during key regulatory events.
• Hybrid model of work.
• Please note that the role requires a candidate to be a holder of work permit & residency in Poland.

About Biogen Poland

Our Warsaw office is a complex hub for local, regional and global roles. Regardless our role and reporting line we’re driven every day by our unique purpose, working passionately to change the lives of patients affected by rare and devastating diseases. This is what gives us pride, inspires us and gives us fuel to push the boundaries of innovation. We represent over 30 nationalities and celebrate the strength that comes from differences in backgrounds, experiences, and perspectives. This commitment to fostering a supportive and inclusive workplace earned us a Great Place to Work Certificate and Best Places to Work Awards consecutively since 2021 in Poland and Europe. If our mission resonates with your heart and career aspirations, we’re inviting you to join our team.

About Global Business Services (GBS)

The Global Business Services (GBS) team transforms Biogen’s business processes, scaling global operations and fueling commercial growth and innovation. GBS adds value by delivering business solutions and support services through a global delivery model, operational transparency, and best practices. Aiming to be a world-class organization, GBS excels in people, solutions, execution, and partnerships, championing a continuous improvement culture recognized across Biogen. We form a great team of individuals with drive for innovation but also team players collaborating in the spirit of respect. And if you want to take your professional development in your own hands, this is a place for you. We give you a lot of opportunities for growth on a business and social ground.

Job Level: Management

Additional Information

The base compensation range for this role is: zł166,000.00-zł228,250.00

Benefits

Competitive Total Rewards: Base salary is determined by your experience, skills, and internal equity, complemented by an annual bonus to recognize your performance and contributions.

Comprehensive Benefits for You and Your Family: Includes life insurance, pension program contributions, mental health resources, remote work allowance, and flexible work arrangements.

Learning, Growth & Recognition: Access professional development funding, training platforms, employee referral bonuses, opportunities to contribute to impactful projects at Biogen, and social activities.