Director, Audit Management, Small Molecule (Remote)
Full Time
Boston, MA 02110
$173,600 - $260,400 a year
Posted
Job description
Job Description
The Director, Global Compliance Small Molecule (SM), as part of the Global Quality Compliance group within the Vertex Quality Assurance Organization, is responsible for risk based GMP/GDP auditing and compliance programs for CMC SM platform of products. This position provides compliance oversight of facilities / processes associated with internal-external manufacturing and testing, distribution, and vendors. It includes responsibilities such as audit and inspection management, inspection management readiness activities, regulatory intelligence interpretations, CMC project / new product introduction support, and product lifecycle initiatives. This position leads a team of compliance experts’ oversight of key Vertex CMC activities regulated by international regulatory bodies, while continuing to work closely as liaisons with Quality Operations and key business partners globally.
This individual will be responsible for design and execution of risk-based approaches related to the audit of CMC activities, conducted both internal to Vertex and at their respective CDMOs/distributors, assuring adherence to applicable regulations, industry standards, and to Vertex policies, procedures and quality standards as set forth in the Quality Management System. This Director will provide strategic input and execution of audits and projects, identify and communicate compliance risks, and oversee applicable risk mitigation plans. The role also includes representation to interdepartmental teams advising teams of CMC Audit outcomes. This individual will provide input and guidance in the development of Vertex’s Audit plans across CMC areas and have budget responsibilities for the identification, qualification, and oversight of external audit organizations.
Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with experience in risk-based compliance programs and who thrives in an environment with an ability to shape an evolving compliance program in support of this expanding team.
Position may require up to 30%
domestic/international
travel
.
Key Duties & Responsibilities
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Serves as Lead of the GMP/GDP Audit function with responsibility for the overall strategic direction, performance, and effectiveness of the audit program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with GMP/GDP regulatory requirements and guidances.
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Partners with QA leadership (e.g., QA Vendor Management, Quality Information Systems Management QA, Operational Area QA) and business leadership for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement across vendors and internal operations (e.g., audit planning, review of audit outcomes, and corrective/preventive action development and implementation).
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Directs the development and maintenance of the integrated and risk based GMP/GDP Audit Plan and provides leadership in setting the direction to plan development, execution, and adherence. Partners with and engages stakeholders and leadership across functional areas and QA in risk evaluation when determining the internal audit schedule.
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Serve as a key advisor, support, and Subject Matter Expert (SME) for critical compliance activities as necessary, including due diligence, integrations, mock Pre-Approval / Pre-License Inspections (PAIs / PLIs), licensing and acquisition, regulatory agency interactions, regulatory inspections, inspection readiness, recovery/remediation, decommissioning, divestiture, and critical new product strategies.
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Participate and provide inputs in Quality Operations management / risk register reviews.
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Collaborates with other leaders in Global Quality Compliance department to provide strategic direction and alignment of risk-based approaches, ensuring that CMC (GMP/GDP) audits strategies and processes are established to:
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Enable the execution of GMP/GDP Vendor qualification and requalification audits.
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Provide oversight, including budget forecast and tracking, for audits that are outsourced.
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Execute directed or For-Cause audits, as needed.
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Responsible for inspection management processes for GMP/GDP and engages in preparation, support and follow-up activities for Inspection Readiness.
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Supports due-diligence and business development activities, as requested.
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Provides GMP/GDP compliance support for Quality Management System initiatives:
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Participates in collaborative review of associated Standards/SOPs/Wis.
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Reviews and analyzes key performance indicator (KPI) data and trends.
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Analyzes risk and proposes remedial, corrective and /or preventive actions.
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Participate on product / process improvements.
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Provides cross-functional support across Vertex Quality Assurance team and effectively partners with key stakeholders, business partners and external organizations.
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Provides functional area leadership and management of Compliance Team Members through the execution of the following:
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Responsible for a team of 5-10 compliance colleagues.
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Performance Management (goals, monitoring, reviews).
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Employee Learning and Development - Identification of training needs and support of aspirational goals via Individual Development Plan (IDP).
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Talent acquisition including recruiting, interviewing, selection, and onboarding.
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Succession planning and talent reviews.
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Forecasting / allocation of resources.
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Participation in QA Business Reviews, as required.
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In-depth knowledge in the following areas:
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GMP/GDP Audit processes
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Global GMP regulations; 21 CFR Parts 210/211/610/820/11/1271 and applicable FDA guidelines, ICH guidelines, EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines / Annexes, and applicable international equivalents
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CMC Manufacturing / Documentation (e.g., NDA, BLA Submissions.)
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Quality System Elements
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Deviation / OOS Investigations, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques
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Risk Management Principles / Risk-based Programs
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Process Validation and Continuous Process Verification
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Contamination Control Strategies
Required Experience
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M.S. (or equivalent degree) and 10+ years of relevant QA and Compliance experience, or
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B.S. in a scientific or allied health field and 12+ years of relevant QA and Compliance experience, audit program development/maintenance and execution using risk-based frameworks in GxP environment, or relevant comparable background.
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5+ years’ experience in a Quality Management role
Pay Range: $173,600-$260,400 USD annually
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
#LI-Remote
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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