Director, Regulatory Quality, Compliance & Communications (Boston, MA)


Job description

 

 

 

 

Position Summary

 

The Director will be responsible for developing and executing a focused effort to improve operational effectiveness of GRA globally. This role will partner with RALT and countries to enhance implementation and adoption of processes and systems, and preparation of relevant communications, with an overall goal of increasing efficiency and compliance.

 

The Director RQCC Global Regulatory Operations will be responsible for managing all quality, compliance and relevant operational activities (eg, compliance, training, team meetings, and special projects) related to daily activities of GRA (considered as the regulatory compliance officer).

 

 

 

Principal Responsibilities

 

The RQCC Director will

 

 

    • Analyze and measure the effectiveness of existing business processes within the GRA and Identify gaps and key areas for improvement
        • Establish and implement KPIs and analytics for performance measurement

 

    • Work effectively with GRA stakeholders to understand functional interdependencies, assess impact on effective process, and develop mutually agreed optimized process

 

    • Facilitate design and implementation of (internal GRA and cross-functional) re-engineered business processes to maximize efficiency and compliance
        • Establish and lead/facilitate a cross-functional team (or initiative) for regulatory submission process improvement (a standing committee)
        • Lead Change Management activities with regard to process enhancements and implementation.
        • Lead the standardization and harmonization of processes across GRA and cross-functionally (when applicable)

 

    • Develop process to reduce barriers for use of collaborative tools, allowing more efficient and effective global and functional information sharing and collaboration.

 

    • Ensure training is adequately performed by team members, send reminders and keep up to date training records

 

    • Write corporate policies and procedures for GRA activities and develop compliance programs

 

    • Perform the duties as the Regulatory Compliance Officer

 

    • Actively support Global Regulatory Affairs activities for internal and external government agency audits and respond to audit findings

 

    • Support major Departmental activities and meetings (Global GRA meetings, Town Halls, etc.)
        • At times, facilitate workshops or training sessions

 

    • Help Global GRA Head, GRO Head and RALT with developing communication strategy and preparation of announcements, communications and periodic newsletter, when needed
        • Manage Distribution Lists for the GRA communications
        • Contribute content to GRA SP Site.

 

 

Qualifications

 

 

    • Experience in the pharmaceutical industry with 8+ years in Regulatory Affairs, and with 5+ years in Regulatory Operations leading role

 

    • Strong communications skills: oral & written, with proven negotiation skills, and ability to prepare communications and periodicals

 

    • Excellent time-management skills

 

    • Must have the ability to work within a global team framework and maintain a global perspective

 

    • Ability to lead and respond to changing environment

 

    • A critical logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution

 

    • Demonstrated solid experience in Project Management: The ability to multitask and manage multiple changing priorities

 

    • General Regulatory and Life Sciences knowledge

 

    • Proven ability to work under pressure and adhere to deadlines

 

    • Strong analytical skills and ability to interpret data and make strategic decisions around regulatory strategy

 

    • Demonstrated high performance orientation, detail orientation, organization skills, and market knowledge

 

    • Excellent written, listening, and verbal communication skills as well as analytical skills

 

    • Demonstrated strong influencing skills and consensus building skills

 

    • Strong awareness and excellent skills in using technology, tools and methodologies/approaches for development and implementation of new processes and their adoption.

 

    • Prior people’s management and mentoring experience is desirable

 

 

 

 

Education

 

 

    • Degree in bio-pharma-related area is desirable, and higher education degree is preferred

 

 

 

 

 

 

Boston, MA, United States
 

 

 

Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

 

 

 

Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.

 

 

 

Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.

 

 

 

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexion.com.

 

 

 

Alexion is an Equal Opportunity /Affirmative action employer

 

Click here to apply.


Related Post