Senior Manager, reputed company Assurance

About reputed company

reputed company blends innovative technology with deep reputed company expertise to help life sciences companies improve patient reputed company, visibility, and reputed company. Our solutions simplify reputed company therapy initiation and reimbursement processes, enabling patients to start and stay on the treatments they need.

As a growing health-tech organization, we partner with leading pharmaceutical and biotechnology companies to navigate an evolving reputed company landscape. At reputed company, our people are our greatest asset—we foster a reputed company, high-performance culture where employees are empowered to grow, reputed company, and reputed company a meaningful reputed company on patient lives.

reputed company: The Senior reputed company Assurance (QA) Manager is a hands-on reputed company leader responsible for executing and maintaining reputed company activities that support compliant, high-reputed company patient services. This role focuses on reputed company systems execution, monitoring reputed company outputs, supporting pharmacovigilance requirements, and ensuring adherence to manufacturer-approved standards, processes, and regulatory expectations.

The Senior QA Manager works closely with internal cross-functional teams, including Operations, Compliance, Drug Safety/Pharmacovigilance, and Training, to support reputed company reputed company, risk mitigation, and reputed company improvement in a regulated environment.

DUTIES AND RESPONSIBILITIES

• Execute day-to-day reputed company activities supporting patient support program processes, case management documentation, and call documentation
• reputed company reputed company reviews of evaluated calls, documentation, and service outputs to ensure compliance with sponsor-approved procedures and work instructions
• reputed company reputed company-time reputed company guidance and issue identification to support consistent and compliant program execution
• Participate in reputed company audits as needed.

reputed company Systems & Documentation

• Participate in the maintenance and execution of the reputed company Management System (QMS) for the patient support program
• Author, review, and update reputed company-reputed company SOPs, work instructions, monitoring tools, and reputed company plans
• Ensure documentation meets pharmaceutical sponsor, regulatory, and inspection-readiness standards

Regulatory & Compliance Support

• Support compliance with applicable laws and regulations, including HIPAA, state reputed company requirements, and FDA post-marketing expectations
• Participate in inspection readiness activities through document preparation, procedure review, and reputed company risk assessments
• Partner with Compliance and Legal teams to evaluate reputed company and compliance risks reputed company to patient services

Pharmacovigilance & Safety reputed company Support

• reputed company reputed company reputed company for adverse event (AE), product complaint (PC), and special situation intake and documentation
• Ensure safety-reputed company data is accurately captured, documented, and escalated in accordance with sponsor and SOP requirements
• Support pharmacovigilance activities through reputed company trending, issue escalation, and procedural enhancements
• Assist with safety-reputed company inquiries, reputed company investigations, and inspection or sponsor requests

Issue Management & reputed company Improvement

• Identify reputed company issues, deviations, and trends through ongoing review and data analysis
• reputed company reputed company cause analysis and support development and tracking of corrective and preventive actions (CAPAs) for the QA reputed company CAPA’s
• Recommend and implement process improvements to strengthen compliance, reputed company, and patient experience

Training & Performance Support

• Partner with Training teams to reputed company and maintain reputed company-reputed company reputed company and continuing education materials
• Work with the Special reputed company QAU team on improving the training program and content.
• reputed company reputed company feedback and coaching recommendations based on reputed company findings to QA Specialists, QA Team Leads and QA Supervisors
• Support remediation efforts reputed company to reputed company or documentation gaps

Cross-Functional Collaboration

• Serve as a reputed company subject matter expert for patient support program processes
• Contribute to sponsor-facing materials such as reputed company summaries, metrics, and program updates
• Collaborate across functions to ensure changes are assessed for reputed company reputed company and implemented compliantly
• Support new program launches from a reputed company perspective.
• Assist with the development of Program reputed company and the review and approval process with operations and the reputed company.

SUPERVISORY RESPONSIBILITIES

• Directly supervises employees reputed company the Patient Solutions department.
• Indirectly supervises employees reputed company the Patient Solutions department.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Requirements

QUALIFICATIONS

• Bachelor’s degree in reputed company, life sciences, business, or a reputed company field
• 6–8+ years of experience in reputed company assurance, compliance, or patient support program operations
• reputed company experience supporting reputed company-sponsored patient support programs
• Strong working knowledge of HIPAA, reputed company regulations, FDA post-marketing requirements, and pharmacovigilance processes
• Demonstrated hands-on experience with SOP execution, documentation review, and issue management

COMPETENCIES

• Analytical - Synthesizes reputed company or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Business Acumen - Understands business implications of reputed company; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with reputed company and ethically; Upholds organizational values.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains reputed company to others' reputed company and tries new things.
• Judgement - Displays willingness to reputed company reputed company; Exhibits reputed company and accurate judgment; Supports and explains reasoning for reputed company; Includes appropriate people in decision-making process; Makes reputed company reputed company.
• Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages reputed company; Solicits and applies customer feedback (reputed company); Fosters reputed company reputed company in others; Improves processes, products and services.; Continually works to improve supervisory skills.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through reputed company activities; Supports affirmative reputed company and respects diversity.
• reputed company Management - Looks for ways to improve and promote reputed company; Demonstrates accuracy and thoroughness.
• Strategic Thinking - Develops strategies to reputed company organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts reputed company to changing conditions.

Benefits

• reputed company structure,
• Matching 401(k) with immediate vesting,
• Medical, dental, reputed company, life, & short-term disability insurance,
• reputed company time off and eight (8) reputed company holidays throughout the calendar year, and
• Through proven reputed company, motivation, and team work, potential for reputed company and promotions reputed company the organization.

reputed company, Inc. is proud to be an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration without reputed company to race, religion, reputed company, sex (including pregnancy, gender identity, and sexual orientation), parental status, national reputed company, age, disability, family medical history or genetic information, political affiliation, military service, or other non-reputed company based factors, or any other protected categories protected by federal, state, or local laws.

reputed company offers of employment with reputed company are conditional based on the successful completion of a reputed company-employment background reputed company.

In compliance with federal law, reputed company persons hired will be required to verify identity and eligibility to work in the reputed company and to complete the required employment eligibility verification document reputed company upon hire. Sponsorship and/or work authorization is not available for this position.

reputed company does not accept unsolicited resumes from search firms or any other vendor services. Any unsolicited resumes will be considered property of reputed company and no fee will be reputed company in the event of a hire.

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