Establish and evolve enterprise delivery governance frameworks, provide independent assurance across programs, and lead automation of governance processes to enhance decision-making and risk management through data-driven insights.

Lead and facilitate industry roundtables, manage senior stakeholder relationships, and develop benchmarking frameworks to provide decision-relevant insights for financial institutions, ensuring structured discussions on emerging risks and regulatory...

• Lead and facilitate commercial process validation and risk management activities across Vaxcyte’s end-to-end manufacturing processes. • Provide leadership to ensure the organization is equipped to effectively design, execute, and communicate process validation and risk management strategies to internal stakeholders, external partners, and regulatory agencies. • Report to the Sr. Director of Process Validation within the Global MSAT organization and collaborate on overall validation strategy. • Provide strategic and scientific leadership for process validation across commercial programs. • Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch. • Ensure alignment of validation activities with regulatory expectations and lifecycle management plans. • Develop and implement risk management frameworks, tools, and processes in collaboration with Quality. • Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks. • Monitor and communicate risk trends and key risk indicators to stakeholders. • Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state. • Contribute to lifecycle management activities, including process improvements and continued process verification. • Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity. • Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies. • Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization. • Support deviation investigations, ensuring timely resolution and sustained compliance. • Contribute to authoring and reviewing regulatory filings and responses to health authorities. • Effectively communicate the scientific and commercial rationale for validation and risk management strategies. • Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance. • Provide guidance on raw material qualification strategies to ensure supply reliability. • Support validation activities across internal and external manufacturing networks. • Communicate process validation performance and risk insights to key stakeholders. • Build strong working relationships and influence across a matrixed organization. • Contribute as a key member of the Global MSAT organization to enable successful commercialization. • Travel - 10-30% domestic and international travel required.

Job Description: Provide competent, age specific health care to women in the Regional Women’s Services and Pediatrics (RWSP) healthcare program. This Advanced Practice Provider will serve as a high risk maternal fetal medicine provider to provide care to both low risk obstetric and gynecology patients as well as care to patients with various medical and obstetrical complications in conjunction with our OB/GYN Maternal Fetal Medicine department. ESSENTIAL JOB FUNCTIONS: Provide health care to the patient and family throughout the course of care. Use the processes of assessment, diagnosis, management, and evaluation to provide care that integrates the psychosocial and physical needs of the patient and family. Establish a therapeutic relationship with the client and family. Plan, develop, coordinate, and provide appropriate health education and counseling in response to patient needs. Contribute to the advancement of the profession, seek to ensure high quality care within the RWSP and department of OB/GYN, and demonstrate leadership skills in achieving improved outcomes for all clients and their families. Responsible for the health care provided and will utilize age specific developmental principles when providing care. This job will require regular travel between the Beaumont RWSP Clinic and Orange RWSP Clinics as well as some occasional travel to the greater Houston area RWSP clinics or Galveston, Texas. MINIMUM QUALIFICATIONS: Master’s in Nursing or Master’s in Physician Assistant Studies FNP, WHNP, CNM or PA license Licensed in the State of Texas with Board Certification PREFERRED QUALIFICATIONS: 2+ years of experience providing Women’s Health Care SALARY: Commensurate with experience. Equal Employment Opportunity UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.