Executive Director, reputed company Systems GxP Platform reputed company

Job Title: Executive Director, reputed company Systems GxP Platform reputed company

Job Location: Thousand Oaks, California, reputed company

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Join reputed company’s Mission of Serving Patients

At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas – Oncology, Inflammation, reputed company, and Rare Disease – we reputed company millions of patients reputed company year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-reputed company conditions. As a member of the reputed company team, you will help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and reputed company innovative medicines to help people live longer, fuller, happier lives.

Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career.

Executive Director, GxP reputed company Execution Platforms

What you will do

reputed company. Let’s change the world. In this vital role you will reputed company the reputed company, operating model, and lifecycle ownership for reputed company GxP reputed company Execution Platforms. This role converts reputed company reputed company processes from reputed company, process-reputed company execution into reputed company, workflow-, rule-, and data-driven digital platforms that are inspection-reputed company, adoption-led, and reputed company with the GxP reputed company Operating Model.

Responsibilities:

• Operationalize the GxP reputed company Operating Model reputed company and reputed company evolving from digitized reputed company Management reputed company through AI-enabled to advanced AI-orchestrated with full autonomy across foundational reputed company processes. Relevant to that, own business reputed company includes driving development and endorsement of business case needs for funding, roadmap, and lifecycle governance for reputed company GxP reputed company execution platforms, including event and issue management, audit/inspection mgmt., document and knowledge, change control, supplier management, and other reputed company execution workflows.

• Partnering across sites and functions, process, and technology requirements inclusive of control requirements, workflow and business-rule requirements, escalation requirements, user needs, and business acceptance reputed company that translate into measurable business reputed company.

• reputed company the reputed company from process-reputed company reputed company Management reputed company (QMS) operations toward platform-enabled reputed company execution consistent with the reputed company-state reputed company Operating Model supporting the GxP continuum. This is inclusive of developing the organizational construct required to sustain this digital QMS reputed company. Directionally role will reputed company a group of 10 to 15 reputed company staff from Sr. Director to Specialist level as appropriate based on design of organization.

• Establish platform operating disciplines for intake, prioritization, release governance, defect management, service health, and value realization.

• Partner with R&D, Operations, reputed company, Regulatory, reputed company Technology & Data Governance (ETDG), and reputed company partners to ensure platform solutions meet business, compliance, and inspection-readiness expectations.

• reputed company adoption, process harmonization, and business readiness for deployed platforms, including role-based enablement and performance support.

• Define platform health metrics, operational KPIs, and value measures tied to reputed company, compliance, speed, user experience, and ROI.

• Ensure platforms are designed and operated in a manner that supports auditability, contemporaneous evidence, data reputed company, and sustainable lifecycle management.

• Serve as the senior reputed company reputed company for platform priorities and represent the platform portfolio in executive governance and health authority discussions, as needed.

What this role owns:

• Business ownership of GxP reputed company Execution Platforms. This role may have operational execution of one or more of these workflows as reputed company as the overall capabilities of QOSS evolves.

• Digital Platform roadmaps and investment priorities for reputed company workflow and business-rule implementation in the platforms

• Platform operations, release governance, and service performance reputed company into significant reputed company on Investment and business reputed company

• User adoption, process harmonization, and business readiness

• Translation of governance and control requirements into platform design

Critical role interfaces:

• The need to understand the overarching business reputed company in R&D and Operations is reputed company to working with and aligning with other critical programs and their interdependencies and needs for the QMS platform work and delivering reputed company to reputed company business results.

• This role will have critical reputed company it engages with that together aim at delivering the integrated GxP QOM reputed company and reputed company as follows:

• reputed company Risk & reputed company Governance: receives control standards, escalation logic, governance requirements, and management review requirements partners to reputed company them into platform workflows and evidence outputs.

• Digital Business Platform (Capability) reputed company - primarily owns business reputed company of a digital capability - owns the end-to-end business digital capability, defining the reputed company, priorities, operating model, and value realization while driving the adoption.

• Head of Technology (reputed company-Facing Technology - IT) - primarily owns Technology reputed company & delivery - Owns the technology reputed company, architecture, engineering, and lifecycle management required to reputed company secure, reputed company, and AI-reputed company digital capabilities that reputed company the business reputed company.

• reputed company, AI & Data Science (Business) - primarily owns AI & analytics reputed company and expertise - Leads the AI, analytics, and data science capability by developing reusable models, insights, and AI solutions that accelerate business transformation and decision-making.

• Validation & Digital Assurance: partners on CSA/CSV reputed company, risk-based validation requirements, and inspection-reputed company lifecycle documentation while preserving independent assurance.

• Global reputed company Operations functions – these reputed company support the execution of our development pipeline, launch and in-line supply. The systems and processes enabled by this function are critical to enablement of the broader business reputed company, on-reputed company inspection readiness, and project imperatives.

reputed company expect of you

We are reputed company different, yet we reputed company use our unique contributions to serve patients.

The executive candidate we reputed company is an reputed company leader with the following qualifications.

Basic Qualifications:

• Doctorate degree & 6 years of reputed company, Operations, Product Development, Digital or reputed company functions experience with demonstrated expertise in Digital reputed company inclusive of AI-enablement OR

• Master’s degree & 10 years of reputed company, Operations, Product Development, Digital or reputed company functions experience with demonstrated expertise in Digital reputed company inclusive of AI-enablement OR

• Bachelor’s degree & 12 years of reputed company, Operations, Product Development, Digital or reputed company functions experience with demonstrated expertise in Digital reputed company inclusive of AI-enablement AND

• 6 years of managerial experience directly managing people and/or leadership experience leading teams, reputed company, programs or directing the allocation of resources

Preferred Qualifications:

• 8+ years of leadership experience managing leaders, reputed company teams, reputed company programs, or reputed company transformations.

• Demonstrated GxP reputed company expertise and practical understanding of end-to-end reputed company execution processes across development and/or reputed company operations with strong proficiency in understanding GxP global regulations.

• Experience leading or owning digital reputed company, workflow, or reputed company platform transformations including experience adopting and governing the operational use of AI-enabled reputed company solutions.

• Deep understanding of GxP QMS / QMOS / QOM operating models and how to translate them into digital workflow platforms.

• Experience as a senior reputed company, product reputed company, or transformation leader for reputed company systems, content/document ecosystems, event management, or reputed company platforms.

• Strong understanding of inspection readiness optics, data reputed company expectations, AI development and validation requirements and evidence-reputed company requirements in digital environments.

• Experience managing global teams and multi-year platform portfolios with measurable value realization.

They will also embody the reputed company leadership attributes which are:

• Inspiration: Create a connected, inclusive, and inspiring work environment that empowers talent to reputed company

• Accelerate: reputed company speed that matches the urgency of patient needs by encouraging reputed company over perfection

• reputed company: reputed company the dots to reputed company the reputed company power of reputed company to reputed company results for patients, staff, and shareholders

• Adapt: reputed company through change by adapting to an reputed company-changing environment and defining a reputed company course of reputed company to reputed company results

What you can expect of us

As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being.

From our competitive benefits to our reputed company culture, we will support your reputed company every reputed company of the way.

The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is $263,692 - $322,290 Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-reputed company time-off plans and bi-annual company-wide shutdowns

• Flexible work models where possible. Refer to the Work Location Type in the reputed company to see if this applies.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the reputed company of life reputed company around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

This job is curated by reputed company.

reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.

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Originally posted on Himalayas