Manager, Quality Assurance & Regulatory Affairs

Manager, Quality Assurance & Regulatory Affairs

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Location(s): Cambridge, MA, Columbus, OH, Customer Site - AL, Customer Site - CA, Customer Site - CO, Customer Site - DC, Customer Site - FL, Customer Site - IL, Customer Site - KS, Customer Site - MO, Customer Site - NJ, Customer Site - PA, Customer Site - TX, Customer Site - VA, Framingham, MA, Indianapolis, IN, Kenilworth, NJ, Norwood, MA, Pasadena, CA, Portland, OR, Princeton, NJ, Rahway, NJ, Raleigh, NC, Redwood City, CA {+ 6 more}

Job Description: This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will work remotely and be willing to travel domestically to meet client project requests, including short-term full time work on client sites.

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 Manager QA/RA is a mid-career professional or highly experienced individual responsible for supporting project execution through technical contribution, analysis, and problem-solving within defined scope and guidance. This role applies intermediate technical expertise on more than one subject to solve complex problems, contributes meaningfully to project outcomes, and demonstrates increased independence in executing assigned work. Managers 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 Manager QA/RA is a deeply experienced contributor who serves as a subject-matter expert and drives complex workstreams from planning through execution. This role applies advanced technical expertise and strong understanding on multiple subjects and project objectives to solve complex problems, influence technical direction, and deliver high-quality outcomes. Senior Managers independently lead workstreams, proactively identify risks and improvement opportunities, and ensure alignment with client and business expectations. They act as trusted members of project teams and stakeholders while demonstrating leadership through mentorship, quality ownership, and cross-functional collaborations. This role requires strategic problem-solving, sound judgement, and a high level of accountability in driving results. The Senior Manager may work across multiple projects or with multiple functional areas. This role is accountable for team performance, talent development, and consistent execution of business priorities, while partnering with senior leaders to drive continuous improvement, scalability, and organizational effectiveness.

Key Responsibilities:

Tactical Client Delivery (Primary Focus): Serve as a delivery leader on tactical quality and regulatory engagements, including but not limited to:

• Quality Management System (QMS) remediation
• Investigation activities
• Submission support
• Supplier Quality Audits
• New Product Introduction QA/RA support
• Ensure delivery excellence, regulatory rigor, and strong client outcomes across all engagements.

Billable Utilization & Project Leadership:

• Maintain high billable utilization consistent with consulting expectations.
• Travel as required to support client projects and audits.
• Act as senior engagement contributor.

Business Development & Market Support:

• 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.
• Remain at the forefront of US, EMA, and ROW regulatory changes and current expectations

Attributes for Success:

• Technical Delivery: Applies advanced technical knowledge and professional expertise
• Innovation & Continuous Improvement: Seeks better ways, adapts to change and champions new ideas.
• Customer Focus & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Integrity & Humility: Demonstrates self-awareness and puts PF mission above ego
• Collaboration & Communication: Communicates clearly and proactively and drives transparent alignment with clients.
• Project Execution: Delivers reliably, manages priorities and drives for high quality outcomes
• Growth Mindset: Shows openness to new ideas, feedback and change

Experience Required:

• Bachelor's degree in scientific, regulatory, engineering, or related discipline preferred.
• 10 years (Manager) -17 years (Sr. Mgr) 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.

Other Preferred:

• Strong communicator and influencer across multiple disciplines.
• Is able to easily achieve agreement and collaborative resolution to project issues.
• Structured thinker with advanced troubleshooting and problem-solving skills.
• Skilled at managing multiple priorities in a high pressure, regulated environment.
• Ability to manage scope and track project changes
• Demonstrated leadership and mentorship abilities.

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.

PerkinElmer 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.