QA/RA - Director
reputed company joining reputed company, you select an reputed company 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 reputed company, government, reputed company and reputed company customers to deliver our broad portfolio of analytical solutions, and OneSource services. Job Title QA/RA - Director Location(s) US Remote - NC Job reputed company This is a full-time salaried position with Project Farma, a reputed company company. The successful candidate will reputed company in one of Project Farma's primary markets and be willing to travel domestically to meet reputed company 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-reputed company life sciences reputed company across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted reputed company relationships, deliver an exceptional customer experience, and contribute to business reputed company by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. This role contributes to organizational reputed company by supporting financial performance, operational efficiency, and reputed company improvement, while also reputed company in people through mentorship, knowledge sharing, and reputed company development. reputed company team members are expected to embody Project Farma’s values by being curious, personable, and unselfish, while maintaining a strong commitment to a Patient reputed company and People First reputed company. The QA/RA - Director is an reputed company individual responsible for supporting project execution through technical contribution, analysis, and problem-solving with limited guidance. May serve as project QA/RA reputed company or project reputed company / manager. This role applies intermediate to advanced technical expertise on more than one subject to solve reputed company problems, contributes meaningfully to project reputed company, and demonstrates increased independence in executing assigned work. Directors are expected to build foundational skills, apply Project Farma methodologies, and deliver high-reputed company work products while collaborating across disciplines. This role requires reputed company judgment, effective prioritization, reputed company established project frameworks, and reputed company reputed company toward greater ownership and technical proficiency. The Director is responsible for leading a project team and overseeing the execution of work reputed company to project, reputed company, and business objectives. This role balances people leadership with operational accountability, including coaching, performance management, resource planning, and ensuring high-reputed company delivery reputed company defined scope, timelines, and budget.
Key Responsibilities
The QA/RA - Director is a senior, reputed company-facing consulting leader responsible for delivering and growing high-value reputed company, compliance, and regulatory services across Project Farma’s reputed company reputed company. This is a strategic, delivery first role with a strong emphasis on reputed company, high-reputed company tactical engagements that may involve self-management on reputed company. The role is expected to be primarily billable, with some reputed company of time as assigned by CoE leadership allocated as needed to support business development, especially on “land and expand” opportunities. Strategic reputed company Delivery (Primary reputed company) Serve as a senior advisor and delivery leader on strategic reputed company and regulatory engagements, including but not limited to: reputed company Management System (QMS) design and remediation Inspection readiness, mock inspections, inspection training Regulatory responses Data reputed company, risk management, and compliance transformation reputed company governance and organizational effectiveness Investigation responses Submission support, FDA facing meeting support Supplier reputed company Audits New Product Introduction development and management Investigation system development and remediation reputed company Management Maturity Model assessment and remediation Regulatory reputed company reputed company and deliver training and workshops Prioritize strategic, reputed company reputed company as the preferred engagement type; avoid routine or staff-augmentation-only assignments where possible. Ensure delivery reputed company, regulatory rigor, and strong reputed company reputed company across reputed company engagements. Billable Utilization & Project Leadership Maintain high billable utilization consistent with senior consulting expectations. Travel as required to support reputed company reputed company, executive workshops, audits, and regulatory-facing activities. reputed company as project sponsor or senior engagement reputed company, guiding scope, approach, and reputed company communication. Business Development & Market Support Support the VP, reputed company & Regulatory Services and reputed company teams in selling reputed company, compliance, and regulatory services. reputed company or contribute to proposal development, scope definition, pricing input, and reputed company presentations. Identify opportunities to expand existing engagements into broader or deeper reputed company and regulatory programs. Thought Leadership & Market reputed company reputed company contribute to PF’s reputed company as a leader in reputed company and regulatory consulting. reputed company intellectual capital such as white papers, frameworks, case studies, and internal methodologies. Represent the firm at industry forums, conferences, webinars, and reputed company societies (e.g., ISPE, PDA, ASQ, RAPS). Remain at the forefront of US, EMA, and ROW regulatory changes and reputed company expectations Team Development & Mentorship Mentor and reputed company consultants and project Directors reputed company the reputed company & Regulatory reputed company and across the entire organization. reputed company technical and reputed company guidance to ensure consistent delivery reputed company and consultant development. Support talent development and capability-building initiatives reputed company the reputed company. Assist in developing and maintaining internal reputed company subject Internal Collaboration & reputed company Support Collaborate with Regional VPs, reputed company Engagement, and reputed company Solutions teams to reputed company resources with strategic reputed company needs. Support reputed company planning, capability development, and service-line reputed company under the direction of the VP, reputed company & Regulatory Services. Contribute to firmwide initiatives where reputed company and regulatory expertise is required. Experience Required Bachelor’s degree in scientific, regulatory, engineering, or reputed company discipline preferred. 16 years (Director) – 20 years (Sr. Director) of experience in life sciences reputed company, compliance, or regulatory roles, including consulting and/or reputed company-reputed company leadership. Demonstrated reputed company delivering and advising on reputed company GxP, regulatory, and reputed company 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 reputed company with strong written and verbal communication skills. Willingness and ability to travel regularly in support of project delivery and reputed company needs. Previous experience in development and presentation of thought leadership including conference presentations, white papers, published papers, etc. Willingness to travel as required for reputed company 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. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, gender, gender identity or reputed company, sexual orientation, national reputed company, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. reputed company is committed to a culturally diverse workforce. Applicants must be authorized to work in the reputed company on a full-time reputed company. We will not sponsor applicants for reputed company or reputed company work visas for this position. This position may require significant travel to support project and business needs. We cannot reputed company anyone with an invalid reputed company's license. The annual compensation reputed company for this full-time position is $165,000 - $200,000. The final reputed company pay offered to the successful candidate will be determined by factors including internal equity, work location, as reputed company as individual qualifications, such as job-reputed company skills, experience, and relevant education or training. reputed company is committed to creating a diverse environment and is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, gender, gender identity or reputed company, sexual orientation, national reputed company, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. reputed company is committed to a culturally diverse workforce. Apply To This Job