In Operations, we turn molecules into medicine and are unified in our commitment to deliver more medicines to more patients more quickly. We are the critical link that brings innovation from our science labs to patients around the world.

We're achieving all of this while continuing to accelerate our operational excellence through innovative science, Lean ways of working, and evolving digital technologies.

Using cell therapy to halt and reverse disease, restore damaged organs, and, ultimately, cure many life-threatening conditions is now a realistic goal for our scientists and operators.

About Rockville Manufacturing Centre (RMC):

Our role in Operations is to bring these promising therapies from the lab to life through a thorough process of development, manufacturing, testing and supply.

Our fast-paced, growing environment provides a wealth of opportunity and global opportunities to learn from other teams, embrace lifelong learning and build capabilities, setting your own direction and pace for your long-term career.

Introduction to role:

Are you ready to develop an attitude of excellence? Join AstraZeneca's Operations team as the Quality Systems & Compliance Associate Director, Cell Therapy at the Rockville Manufacturing Centre (RMC) facility, the newest addition to our global supply network.

We aim to make a direct impact on patients by delivering life-saving cell therapies. This is your chance to break new ground and leave a collective legacy!

Accountabilities:

As the Quality Systems & Compliance Associate Director, Cell Therapy, you will provide leadership, direction and mentoring to ensure that the QS/C organisation is successful in meeting the quality and manufacturing objectives in support of site goals.

You will represent the QS/C department and/or the Quality Organisation on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure results are aligned with site business objectives.

You will facilitate the growth and development of QS/C staff, provide strategic support to the Quality Site Lead, Compliance and Site Support, for operational and long-term growth, and demonstrate excellent communication skills through internal and external channels.

Essential Skills/Experience:

• B.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience

• Minimum of 2 years of management/supervisory/project management experience

• Experience in audit and inspection management

• Consistent record of working in a fast-paced, cross-functional work environment

• Excellent written and verbal communication skills

• Team oriented approach to project management and problem resolution

• Proven record of making decisions that balance patient safety, compliance, and supply

• Ability to influence senior collaborators, both internally and externally

• Ability to multi-task and prioritise work

Desirable Skills/Experience:

• M.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience

• Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field

• Experience with Quality Systems (e.g. Veeva Vault) is desirable.

• Experience with Cell Therapy regulatory inspections

• Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance.

• Experience engaging with global regulatory bodies

• Consistent track record of attracting and developing talent

Benefits:

AstraZeneca offers a competitive salary range of $129,556.80 - $194,335.20 USD Annual, a short-term incentive bonus opportunity, eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Benefits offered include a qualified retirement program (401(k) plan), paid vacation and holidays, paid leaves, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an 'at-will position' and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At AstraZeneca, we champion a perspective of excellence. Our environment is driven by a belief that good can always be better. We continuously seek opportunities to contribute by harnessing science and evidence to foresee risks. It's a place where innovation thrives as we focus on delivering life-changing medicines to patients.

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Key responsibilities include:

• Leading and engaging with US Sales, HCP Operations, Sales Operations & Insights, and Marketing stakeholders to ensure key business strategies can be broken down to effective, measurable, and scalable processes.
• Partnering with the Director and other AD to oversee day-to-day team operations, including workload visibility, prioritization, clear direction setting, and handling escalations as needed.
• Scoping, delivering, and scaling meaningful CRM and other sales optimization platforms, minimizing duplication, reducing work in the system, and enabling field teams to reach their customers more effectively and efficiently.
• Driving system and process adoption through strategic and operational change management activities, including presenting to and obtaining buy-in with senior leadership.
• Managing the rollout of system enhancements, from impact assessment and readiness planning to training, communications, and post-launch adoption tracking and reinforcement.
• Being the CRM Lead/SME for product launches and collaborating across departments to ensure go-live readiness upon product approval.
• Boosting virtual or digital activities across all of US Commercial, including Marketing Material Digitization and Optimization.
• Establishing and managing vendor relationships and investigating new system enhancements to continuously improve and optimize the use of existing platforms.
• Supervising and facilitating the resolution of critical Veeva system issues in coordination with IT.
• Representing the department in cross-functional projects to ensure that operations and digital interests and requirements are accounted for.
• Understanding the technicalities of CRM to cultivate successful partnerships with IT.

Requirements include:

• A Bachelor's degree.
• 5+ years of experience in implementing, managing, or enhancing Salesforce CRM, Veeva Suite (CRM, PromoMats, Align), and/or related platforms.
• Pharmaceutical industry experience, including product launches.
• Excellent business process optimization and business requirements gathering skills, with a focus on building scalable systems and processes.
• Proven ability in effectively working with and managing cross-functional teams, successfully navigating between Business and IT stakeholders.
• Excellent presentation and communication skills, with the ability to interact with senior management.
• Advanced PowerPoint or equivalent software skills for making strong presentations to key stakeholders.
• Advanced Excel or equivalent software skills for data analysis.
• Strong analytical thinking and problem-solving ability.
• Highly proactive and resourceful to excel in a fast-paced environment.
• Strong project management, delivery, and risk management skills.
• Vendor management experience, including offshore.

Preferred qualifications include:

• Veeva CRM or Salesforce.com certification.
• Experience in rare disease Pharma.

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This role involves working across multiple functions (IBEX, IT, Sales, Brands, Compliance) to balance the immediate demands with future capabilities needed to deliver the US Business strategy.

The Associate Director will shape and deploy ongoing evolutions in AZ's CRM capability, especially with respect to enhancements in our omnichannel capabilities.

In exchange for a fast-paced environment, this role offers significant opportunities for leadership exposure and professional development.

Accountabilities:

• Strategic brand alignment: Possess a deep understanding of brand strategy, performance drivers, and unmet needs to co-create high impact initiatives for customer-facing teams.

• End-to-end orchestration: Coordinate across all IBEX stakeholders to deliver integrated, end-to-end solutions that align with brand objectives and field execution.

• Innovation: Partner closely with IT to maximise adoption and effectiveness of AstraZeneca technology solutions across customer-facing roles.

• Testing, deployment, and change governance: Plan, execute, and govern testing and deployment activities for new and enhanced CRM capabilities, ensuring readiness and minimal disruption.

• Process optimisation: Continuously identify and prioritise opportunities to streamline processes and improve efficiency across workflows and systems.

• Outcome orientation: Focus on business outcomes and customer-facing productivity to demonstrate impact beyond deployment.

• US market representation and scalability: Represent US market needs in 'CRM of the Future' initiatives and share best practices with global teams to shape scalable, market-relevant solutions.

Required skills:

• Bachelor's degree; preferably in a relevant subject area.

• 5+ years of pharmaceutical/biotech experience.

• Experience with Veeva, Salesforce or other CRM platforms.

• Ability to influence others without authority.

• Previous experience in a cross-functional, collaborative, problem-solving team environment.

Preferred skills:

• Pharmaceutical sales experience.

• Experience with development and support of CRM or other technology capabilities.

• Thought leader on current capability-building best practices.

• Knowledge of sampling as well as digital marketing and engagement capabilities.

• Proven capability in influencing a diverse network of senior leaders and stakeholders.

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The role reports to the Director of Clinical Operations, Dennis McHugh. This role will be a Remote role with occasional travel, as required, to our Brisbane, California headquarters.

Responsibilities:

• Ensure compliance with standard protocol and regulatory and ICH GCP obligations in assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials.
• Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification for accuracy and integrity, as required.
• Write and submit reports of investigational site findings and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.

Requirements:

• Minimum Bachelor’s degree in a life science-related field, a registered nurse (RN) certification, or equivalent.
• 3+ years’ experience in a clinical trials research environment required, with specific in vitro diagnostics study experience.
• General knowledge of regulatory requirements & GCP.
• Ability to multi-task, deal with shifting priorities, and proactively solve problems/manage risks.
• Strong interpersonal, collaborative, and time management abilities.
• Excellent organizational skills; accurate and detail-oriented.
• High proficiency in Veeva Vault and Medrio.
• Strong spoken and written communication skills.

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