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QA/RA - Director

$165k - $200k

PerkinElmer

Job Title QA/RA - Director Location US Remote - NC Job Summary Project Farma, a PerkinElmer company, is seeking a senior consultant to lead QA/RA engagements and support project execution across the life sciences project lifecycle. The role combines client‑facing strategy, operational leadership, and technical expertise in quality, regulatory, and compliance areas while driving financial, operational, and business growth.The Director will serve as a senior advisor and delivery leader on strategic quality and regulatory engagements, including quality management system design, inspection readiness, regulatory responses, data integrity, supplier audits, new product introduction, regulatory strategy, and more. The position is primarily billable, involves frequent domestic travel, and requires involvement in business development, thought leadership, and team mentorship.Project Farma promotes a culture of curiosity, people‑first mindset and patient focus. All applicants will be considered under equal‑opportunity guidelines. Key Responsibilities Strategic Client Delivery (Primary Focus) Serve as a senior advisor and delivery leader on quality and regulatory engagements, including quality management system design and remediation, inspection readiness and mock inspections, regulatory responses, data integrity, risk management and compliance transformation, quality governance and organizational effectiveness, investigation responses, submission support, supplier quality audits, new product introduction development, investigation system remediation, quality management maturity model assessment, regulatory strategy, training workshops and more. Prioritize strategic complex projects over routine engagements, ensuring regulatory rigor and client outcomes. Billable Utilization & Project Leadership Maintain high billable utilization consistent with senior consulting expectations; travel as required to support client projects, workshops, audits, and regulatory‑facing activities. Act as project sponsor or senior lead, guiding scope, approach, and client communication. Business Development & Market Support Support the VP of Quality & Regulatory Services and commercial teams in selling quality, compliance and regulatory services. Lead or contribute to proposal development, scope definition, pricing input, client presentations and identify opportunities to expand existing engagements. Thought Leadership & Market Presence Develop intellectual capital such as white papers, frameworks and case studies; represent the firm at industry forums, conferences, webinars and professional societies; keep abreast of regulatory changes and expectations across US, EMA and ROW. Team Development & Mentorship Mentor and coach consultants and project directors, provide technical guidance, support talent development, and contribute to knowledge management initiatives. Internal Collaboration & Practice Support Collaborate with Regional VPs, Client Engagement and Client Solutions teams to align resources with strategic client needs, support practice planning and service‑line evolution, and contribute to firm‑wide initiatives requiring quality and regulatory expertise. Qualifications Bachelor’s degree in a scientific, regulatory, engineering or related discipline (advanced degree preferred). 16‑20 years of experience in life sciences quality, compliance or regulatory roles, including consulting or owner‑side leadership. Demonstrated success with GxP, regulatory and quality system initiatives; strong knowledge of FDA, EMA, MHRA, ICH, WHO frameworks; proven ability to support sales and business development; executive presence and excellent written and verbal communication skills. Willingness and ability to travel regularly for client delivery. Preferred: industry‑specific certifications. Must be authorized to work in the United States on a full‑time basis; visa sponsorship not available. Requires a valid driver’s license. Compensation The annual compensation range for this full‑time position is $165,000‑$200,000. Base pay will be determined by internal equity, work location and individual qualifications. Equal Opportunity Employer 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, veteran status or any other characteristic protected by applicable law. PerkinElmer is committed to a culturally diverse workforce. #J-18808-Ljbffr PerkinElmer

Vacancy posted 4 days ago
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