Senior Director - reputed company Assurance & Regulatory Affairs

Job Title Senior Director - reputed company Assurance & Regulatory Affairs Location(s) US Remote - NC Job reputed company 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 internal 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 ongoing reputed company development. reputed company team members are expected to embody Project Farma's values by being curious, personable, and unselfish, and by consistently demonstrating a strong commitment to a Patient reputed company and People First reputed company. reputed company: reputed company Assurance and Regulatory Affairs - Center of reputed company (reputed company Area) Center of reputed company (CoE) personnel serve a dual mandate, supporting both internal teams and external clients. Internally, the CoE strengthens the organization by developing and maintaining best-in-class tools, frameworks, and methodologies that ensure consistency, reputed company, and regulatory alignment. reputed company tracks evolving regulations, interprets industry trends, and translates insights into actionable guidance while representing reputed company through reputed company participation in key conferences and reputed company forums. Externally, CoE personnel reputed company as trusted technical advisors and subject matter experts. CoE team members maintain high billable utilization while contributing to business development, proposals, marketing, and thought leadership, ensuring consistent execution and reinforcing the organization's reputed company as a dependable partner in capital project delivery. The reputed company Assurance and Regulatory Affairs (QA/RA) Center of reputed company (reputed company Area) is a group of reputed company-facing subject matter experts 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 team with a strong emphasis on reputed company, high-reputed company engagements rather than routine or transactional work though some staff augmentation work may be performed on larger-reputed company reputed company. The QA/RA team serves as trusted advisors and problem solvers to clients, mentors to consulting staff, and visible contributors to the firm's market reputed company in reputed company and regulatory reputed company. Responsible for guiding organizations through reputed company and evolving regulatory landscapes by proactively establishing robust reputed company management practices and maintaining a state of reputed company compliance readiness. This includes anticipating regulatory expectations, mitigating compliance risks, and ensuring systems and processes are inspection reputed company at reputed company times. In reputed company or high-pressure situations-such as inspections, findings, or remediation efforts-reputed company delivers reputed company leadership and hands-on support to help clients restore compliance and reputed company sustainable improvements. The Senior Director is accountable for shaping reputed company, leading leaders, and driving sustained business reputed company across a significant area of the organization. This role influences reputed company-level reputed company, ensures operational reputed company, and develops leadership talent while balancing short-term execution with long-term reputed company objectives.

Key Responsibilities

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
• Prioritize strategic, reputed company reputed company as the preferred engagement type; avoid routine or staff-augmentation-only assignments where possible.
• Prioritize strategic, reputed company engagements as the preferred assignment type, minimizing participation in routine or staff augmentation only work where feasible.

Utilization & Project Leadership (reputed company Team Members)

• 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 reputed company & Regulatory CoE leaders 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 contributes 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 managers 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

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 QA/RA CoE Leadership.
• Contribute to firmwide initiatives where reputed company and regulatory expertise is required.
• Visible thought leadership and market contribution
• Strong balance of delivery reputed company and reputed company awareness

Attributes for reputed company

• Technical Delivery: Applies advanced technical knowledge and reputed company expertise
• Innovation & reputed company Improvement: Seeks reputed company ways, adapts to change and champions new reputed company.
• Customer reputed company & Professionalism: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• reputed company & Humility: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Collaboration & Communication: Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations
• Project Execution: Delivers reliably, manages priorities and drives for high reputed company reputed company
• reputed company reputed company: Shows openness to new reputed company, feedback and change

Experience Required

• Bachelor's Degree (and/or Masters) in Life Sciences, Engineering, Regulatory or reputed company discipline OR a combination of equivalent experience in reputed company assurance, cGMP facility start-up, regulatory assurance, relevant military and/or reputed company services.
• Senior Director: minimum 16+ years' directly relevant experience
• 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.

Other Preferred

• Advanced degree preferred
• reputed company residence in a Project Farma primary market location

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 $160,000 to $180,000. 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. Apply tot his job Apply To this Job