Quality Assurance Director

PerkinElmer; Denver (CO); On-site; USD 170,000 - 240,000; Full time

Job summary

PerkinElmer’s Project Farma team seeks a Director QA/RA to lead strategic quality and regulatory engagements in the US. This senior role requires extensive GxP expertise, cross-functional collaboration, and travel to client sites to ensure high-quality deliverables.

Residing in one of Project Farma’s primary markets, you will mentor teams, drive regulatory strategy, and contribute to business growth while maintaining patient-focused outcomes and exceptional client experiences.

Qualifications

• Bachelor’s degree in scientific/regulatory/engineering preferred.
• 16–20 years of life sciences quality, compliance, or regulatory leadership experience.
• Strong knowledge of FDA, EMA, MHRA, ICH, WHO regulatory frameworks.
• Executive presence with strong written and verbal communication.

Responsibilities

• Lead strategic quality and regulatory engagements and design QMS remediation.
• Support regulatory responses, inspections, and supplier quality activities.
• Mentor consultants and project Directors within the practice.
• Travel to support client projects and executive workshops.

Skills

Executive presence

Communication skills

Travel willingness

Regulatory knowledge

GxP experience

Education

Bachelor’s degree in scientific/regulatory/engineering

Advanced degree preferred

Job description

This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will reside in one of Project Farma's primary markets and be willing to travel domestically to meet client project requests.

Project Farma’s purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.

This role contributes to organizational success by supporting financial performance, operational efficiency, and continuous improvement, while also investing in people through mentorship, knowledge sharing, and professional development.

All team members are expected to embody Project Farma’s values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient Focused and People First mindset.

The Director QA/RA is a deeply experienced individual responsible for supporting project execution through technical contribution, analysis, and problem-solving with limited guidance. May serve as project QA/RA lead or project lead / manager. This role applies intermediate to advanced technical expertise on more than one subject to solve complex problems, contributes meaningfully to project outcomes, and demonstrates increased independence in executing assigned work. Directors are expected to build foundational skills, apply Project Farma methodologies, and deliver high-quality work products while collaborating across disciplines. This role requires sound judgment, effective prioritization, within established project frameworks, and continued growth toward greater ownership and technical proficiency. The Director is responsible for leading a team and overseeing the execution of work aligned to project, client, and business objectives. This role balances people leadership with operational accountability, including coaching, performance management, resource planning, and ensuring high-quality delivery within defined scope, timelines, and budget.

Key Responsibilities

The role is expected to be primarily billable, with some amount of time as assigned by CoE leadership allocated as needed to support business development, especially on “land and expand” opportunities.

Strategic Client Delivery (Primary Focus)

Serve as a senior advisor and delivery leader on strategic quality and regulatory engagements, including but not limited to:

• Quality Management System (QMS) design and remediation
• Inspection readiness, mock inspections, inspection training
• Regulatory responses
• Data integrity, risk management, and compliance transformation
• Quality governance and organizational effectiveness
• Investigation responses
• Submission support, FDA facing meeting support
• Supplier Quality Audits
• New Product Introduction development and management
• Investigation system development and remediation
• Quality Management Maturity Model assessment and remediation
• Regulatory Strategy
• Develop and deliver training and workshops

Prioritize strategic, complex projects as the preferred engagement type; avoid routine or staff-augmentation-only assignments where possible.Ensure delivery excellence, regulatory rigor, and strong client outcomes across all engagements.

Billable Utilization & Project Leadership

Maintain high billable utilization consistent with senior consulting expectations.Travel as required to support client projects, executive workshops, audits, and regulatory-facing activities.Act as project sponsor or senior engagement lead, guiding scope, approach, and client communication.

Business Development & Market Support

Support the VP, Quality & Regulatory Services and commercial teams in selling quality, compliance, and regulatory services.Lead or contribute to proposal development, scope definition, pricing input, and client presentations.Identify opportunities to expand existing engagements into broader or deeper quality and regulatory programs.

Thought Leadership & Market Presence

Actively contribute to PF’s reputation as a leader in quality and regulatory consulting.Develop intellectual capital such as white papers, frameworks, case studies, and internal methodologies.Represent the firm at industry forums, conferences, webinars, and professional societies (e.g., ISPE, PDA, ASQ, RAPS).Remain at the forefront of US, EMA, and ROW regulatory changes and current expectations

Team Development & Mentorship

Mentor and coach consultants and project Directors within the Quality & Regulatory practice and across the entire organization.Provide technical and professional guidance to ensure consistent delivery quality and consultant development.Support talent development and capability-building initiatives within the practice.Assist in developing and maintaining internal knowledge management subject

Internal Collaboration & Practice Support

Collaborate with Regional VPs, Client Engagement, and Client Solutions teams to align resources with strategic client needs.Support practice planning, capability development, and service-line evolution under the direction of the VP, Quality & Regulatory Services.Contribute to firmwide initiatives where quality and regulatory expertise is required.

Experience Required

• Bachelor’s degree in scientific, regulatory, engineering, or related discipline preferred.
• 16 years (Director) – 20 years (Sr. Director) of experience in life sciences quality, compliance, or regulatory roles, including consulting and/or owner-side leadership.
• Demonstrated success delivering and advising on complex GxP, regulatory, and quality system initiatives.
• Strong working knowledge of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO).
• Proven ability to support sales and business development in a consulting environment.
• Executive presence with strong written and verbal communication skills.
• Willingness and ability to travel regularly in support of project delivery and client needs.
• Previous experience in development and presentation of thought leadership including conference presentations, white papers, published papers, etc.
• Willingness to travel as required for client project assignments.

Other Preferred

• Advanced Degree preferred
• One or more industry-specific certifications

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license.

The annualcompensation range for this full-time position is $170,000 - $240,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.