Director, CMC Regulatory Compliance

Company: Takeda Pharmaceutical
Location: Dayton
Posted on: September 15, 2023

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as a Director, CMC Regulatory Compliance employeeHow you will contribute:The Director of CMC Regulatory Compliance is responsible for the strategic and operational activities pertaining to global and local compliance within Global Regulatory Affairs - Chemistry, Manufacturing and Controls & Devices (GRA CMC).Partners and influences cross functionally with colleagues in Quality Assurance, Compliance, Global Manufacturing and Supply, Pharmaceutical Sciences, Global Regulatory Operations, and Local Operating Companies to drive compliance and continuous improvement.Leads and manages Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and is a point of contact for Regulatory CMC on audits & InspectionsDevelops and manages a program for the tracking, execution, monitoring, and reporting on GRA CMC processes (Metrics and KPIs) to drive excellence in Regulatory CMC pre and post submission activities.Seeks opportunities to build optimized CMC capabilities through digital solutions and automation enablement for optimal execution and compliance.Ensure Regulatory CMC is aligned with and responsive to health authority regulations and guidelines as they pertain to requirements for drugs, biologics, combination products and devices.Collaborates across Global Regulatory CMC to ensure clear and timely communication about compliance risks, business processes, compliance activities and metrics.Partner with CMC LT to support global strategic CMC initiatives related to pre and post submission activities and the processes and systems used to manage compliance.Independently manages oversight of all Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and a robust compliance metrics review program.Ensure CMC inspection readiness and act as a main point of contact with Global Quality and other stakeholders for internal and external auditsEnsure that responses resulting from audit and inspection findings and CAPAs related to GRA CMC are aligned with CMC LT and stakeholders.Ensure GRA CMC Commitments (i.e. IND, post marketing) and Quality Events are managed within specified timelines.Build effective relationships with GRA Compliance and other R&D Compliance departments to develop new and updated end-to-end processes for execution of GRA pre and post submission activities.Escalate issues/problems to CMC LT as needed and propose risk-based remediation actions for considerationProvide input on budgets for the group as appropriateMaintain strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory CMC.CORE ELEMENTS RELATED TO THIS ROLE This role is best suited for someone with proven management experience of staff as well as influence in a matrix structure.Process minded and analytical thinker with demonstrated experience applying risk management principles when implementing compliance solutions.Knowledge of the pre and post submission regulatory requirements on major markets like EU, USA, Canada, U.K. and other international markets.Operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.This role is global and has cross-functional collaboration across multiple parts of the Regulatory, Quality and R&D groups including TAU, MPG, Business Units, and CROs.Quality System Management and Regulatory drug development experience are key for this role to be successful.Systems Knowledge - knowledge of Quality Management Systems including Deviation and CAPA management, SharePoint, and Regulatory Information Management (RIM).DIMENSIONS AND ASPECTS Technical/Functional (Line) ExpertiseRegulatory knowledge of European, US and international regulations relative to pre and post submission regulatory requirements.Industry Knowledge - strong understanding of the pharmaceutical industry and pharmaceutical companies' operations processes and strategies particularly Quality Management Systems, Drug Development, Regulatory Affairs, and Compliance. LeadershipDemonstrated ability to work independently to inspire, motivate, and lead people across functions, regions, and cultures.Excellent communicator, able to persuasively convey both ideas and data, verbally and in writingProven skills as an effective team player who can engender credibility and confidence within and outside the companyAbility to distil complex issues and ideas down to simple comprehensible termsDemonstrates leadership presence and confidenceEmbraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organizationInvests time in helping others to enhance their skills and perform at a higher levelDecision-Making and AutonomyProvide input to complex decisions that impact Regulatory CMCAbility to seek diverse input from multiple constituents and stakeholders to drive innovative solutionsAbility to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Responsible for providing input to and implementing vision and strategy for Regulatory CMCInteractionEffectively navigates the changing external and internal environment and helps lead others through change Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.Ability to build strong relationships and collaborate effectively with other interfacing Takeda functionsInnovationStrategic thinking with the ability to recommend and implement innovative continuous improvement solutions, particularly with automation.Comfortable challenging the status quo and bringing forward innovative solutions Ability to put forth risk based innovative solutions enhancing CMC Compliance, accelerating time to market, business process efficiencies, etc.Identifies opportunities and anticipates changes in the business landscape through a deep understanding of the environment affecting the business and active engagement with relevant cross functional stakeholdersComplexityAbility to work effectively in a global ecosystem (internal and external) with a high degree of complexity Must be able to lead and participate in cross-functional and cross regional teams and deliver results on behalf of CMC Ability to understand the broader, enterprise level perspective when assessing issues and implementing solutionsMinimum Requirements/Qualifications:Bachelor's degree (or equivalent) required. Masters preferred.10 plus years' experience in pharmaceutical industry, with direct Regulatory CMC experience. Direct exposure in QA and/or a Compliance function within the drug development lifecycle a plus.Experience with Health Authority inspections and audits.Knowledge of Global Regulatory Affairs function and the key interactions of GRA necessary to achieve goals and objectives.Ability to identify and measure risk of non-compliance and recommend business process changes in a complex environment.Knowledge of global health authority regulations for pre and post submission activitiesPractical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. Able to manage both time and priority constraints and to manage multiple priorities independently.Capability to critically analyze complex and/or ambiguous information and the impact on products and process.Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.RAPS Regulatory Affairs Certification (RAC) a plus.What Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match of charitable contributionsFamily Planning SupportFlexible Work PathsTuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $156,800- $224,000 based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.Empowering our people to shine:Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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