Director, Quality Systems

Replimune; Framingham (MA); On-site; USD 192,000 - 248,000; Full time

Job summary

Replimune is seeking a Director of Quality Systems in Framingham, MA to lead the development and implementation of quality systems ensuring compliance with US and international regulations. This role reports to the Senior Director, Quality Assurance and involves managing eDMS tools, CAPA, deviation management, and quality metrics across the organization.

The ideal candidate will have 10+ years in QA/QS within the pharmaceutical industry, experience with electronic document systems, inspection

Qualifications

• Bachelor's degree or equivalent is required; advanced degree preferred.
• 10 years' experience in QA/QS in pharma industry.
• Experience with electronic document management systems (eDMS).
• Experience with inspection management.
• Lean, Six Sigma, or operational excellence desirable.

Responsibilities

• Oversee/Manage a compliant and effective Quality System per ICH Q10 components.
• Monitor and report to management on quality system health.
• Drive quality system initiatives and improvement across functions/sites.
• Provide leadership to quality systems staff for consistent customer service.
• Assist with inspection readiness and coordinate CAPA plans within regulatory timelines.
• Implement efficiency improvements and participate in site projects.

Skills

Communication skills

Cross-functional collaboration

Project management

Negotiation skills

Independent work

Team mindset

Education

Bachelor's degree or equivalent

Advanced degree preferred

Tools

MasterControl

Job description

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

Reporting to the Senior Director, Quality Assurance, the Director, Quality Systems supports the development and implementation of Replimune quality systems to ensure compliance with US and international regulations, laws and guidelines including ICH 010.

The Director, Quality Systems has the opportunity to create influential and collaborative relationships for Quality across the company and will be accountable for but not limited to; training, documentation, vendor management, change control, corrective action preventative action (CAPA), deviation management and quality metrics development and reporting. Managing and maintaining eDMS tools are essential to the role, as is management of the international quality systems team.

• This position is based in our Framingham location and typically has a 5-day on-site expectation.

Key responsibilities:

• Oversee/Manage a compliant and effective Quality System as described in ICH Q10 including the following components:
  • Document Management
  • Training compliance
  • Change Control
  • Deviation Management
  • CAPA
  • Quality Metrics Reporting and Trending
• Monitor and report to management on the quality system health
• Drive quality system initiatives and improvement activities while partnering across functions and sites.
• Provide leadership and guidance to elevate quality system issues to all levels of the organization to ensure compliance with industry expectations.
• Provide leadership to the quality systems staff to ensure effective and consistent customer service to the business.
• Assist with inspection readiness activities including reporting and escalating inspection risks along with development and execution of actions focused on risk mitigation. This includes identification of interim controls and influencing stakeholders to drive timely action where mitigation is required and assist with coordinating inspection responses within defined regulatory timelines and generation of the associated CAPA plans.
• Implementing efficiency improvements on a continuous basis and participating in site projects and initiatives.
• Facilitate training of functional areas and develop appropriate training for personnel involved in the execution of Quality System processes.
• Oversee implementation, validation and maintenance and business use of electronic quality system tools (MasterControl).

Experience and skills requirements:

• 10 years' experience working in a Quality Assurance or Quality Systems role in the pharmaceutical industry.
• Experience with electronical documentation systems
• Experience with inspection management
• Project Management/Operational Excellence experience with Lean, Six Sigma, or both desirable.
• Experience working cross-functionally across multiple sites and/or time zones.
• Good verbal and written communication skills to establish rapport and develop relationships with key stakeholders.
• Good conflict management and negotiation skills
• Proven ability to work independently as well as collaborate with peers and working effectively in a team-oriented environment

Educational requirements:

• Bachelor's degree or equivalent required. Continuing education or advanced degree in a biological or pharma industry area preferred.

Salary Range

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $191,500-$247,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.