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Straightforward. Efficient. SIMPLE.

Straightforward.Efficient.Simple.

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Fractional Consulting offers a deeper integration into your company's operations, providing long-term engagement, decision-making authority, and a cost-effective solution. Let's explore some of the most impactful differences between regular consulting and Fractional Consulting. 

Head of QA Fractional Consulting

Why Choose Fractional Consulting? 

QMS oversight

Drive Change

Training Oversight

Hiring/onboarding staff

Serve as QA Rep

While both Fractional and Regular Consulting offer valuable expertise and knowledge, there are some differences in the type of tasks addressed under each category.

 

Regular Consulting:

  • Best for short-term projects or one-time tasks

 

Fractional Consulting:

  • Ideal for continuous oversight of QMS operations or QA staff

  • Provides ongoing, high-level strategic support

  • Focuses on continuous improvement

  • Offers long-term engagement and integration into company operations​​

*Rerefence

01

The use of fractional consultants in the biopharma sector grew significantly, with over 110,000 individuals identifying as fractional leaders in early 2024, compared to just 2,000 in 2022.

02

Fractional leaders are typically senior-level professionals who work part-time for companies, often smaller organizations.

03

Fractional work allows experienced professionals to stay engaged and leverage their vast experience for young startups.

04

The trend is expected to continue rising in response to biotech trends such as downsizing and limited venture capital resources.

Fractional vs. Regular Consulting:
Key Differences

To help you understand the unique advantages of Fractional Consulting, I have created a comparison table to highlight key differences and benefits, so you can determine which service best suits your quality needs.

Title
Regular Consulting
Head of QA Fractional Consulting
Integration and Commitment
Works on specific projects without deep integration into daily operations.
Part-time senior leader involved in strategic decisions and quality operations.
Decision-Making Authority
Provides recommendations, but final decisions rest with the company's internal team.
Has decision-making authority to implement changes and initiatives.
Cost-Effectiveness
Cost-effective but may not offer the same level of integration into daily operations.
Most cost-effective solution for high-level expertise without a full-time executive salary.
Long-Term Engagement
Shorter engagements, focusing on specific projects or deliverables.
Provide long-term continuity and oversight of QA and QMS processes.

My Role as a Head of QA Fractional Consultant

Below are some examples of the tasks and duties that can be done under Fractional Consulting. These can be tailored to meet your specific needs. Schedule a free consultation to discuss how I can support your organization.

QMS Oversight

  • Promote and implement continuous improvement initiatives to ensure the QMS remains lean, user-friendly, and compliant.

  • Manage and assess SOPs and quality processes to analyze compliance, assess risks, and update as needed.

  • Oversee the integration and harmonization of the QMS, promoting efficiency and standardization.

  • Monitor and evaluate the effectiveness of training programs to ensure they meet quality standards.

  • Monitor and evaluate key quality processes such as supplier quality performance and others.

Team Leadership & Development

  • Recruit and onboard QA team members.

  • Lead and manage local and global quality teams to ensure consistent adherence to cGMP standards and regulatory requirements.

  • Conduct regular performance reviews and provide constructive feedback to team members

  • Develop and implement succession plans to ensure continuity in key roles within the QA team.

  • Organize team-building activities and events to foster collaboration and camaraderie.

Strategic Planning & Collaboration

  • Conduct Management Review

  • Develop and implement global quality strategies and initiatives that align with corporate objectives and regulatory expectations.

  • Collaborate closely with cross-functional teams including Manufacturing, Regulatory Affairs, and R&D to drive continuous improvement in quality processes and systems.

  • Engage with key stakeholders to align quality initiatives with business objectives.

  • Oversee quality-related projects to ensure they are completed on time and within budget.

  • ​Facilitate clear and effective communication between cross-functional teams to ensure alignment and collaboration.

Compliance Oversight

  • Present KPIs, initiatives, and resource needs to senior management.

  • Provide vendor oversight.

  • Serve as the primary point of contact for regulatory inspections and audits, ensuring readiness and compliance at all times.

  • Monitor and analyze quality metrics and KPIs to identify trends, implement corrective actions, and drive a culture of quality excellence.

  • Champion a culture of quality and compliance throughout the organization, promoting awareness and accountability at all levels.

  • Oversee the investigation of quality incidents and ensure appropriate corrective and preventive actions are implemented.

Fractional Consulting = Expertise on Demand

Whether hourly or via retainer, allow me to create a solution that fits your budget, timelines, and goals.

Explore our other Services

Explore all other service offerings. Schedule a free 30-minute video consultation or request a quote for additional information. 

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