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Associate Director Gxp Jobs (NOW HIRING)

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Associate Director Gxp information

What is the difference between Associate Director Gxp vs Senior Gxp Specialist?

AspectAssociate Director GxpSenior Gxp Specialist
CredentialsBachelor's or Master's in Life Sciences, GMP trainingBachelor's or Master's in Life Sciences, GMP training
Work EnvironmentLeadership role overseeing teams, strategic planningHands-on compliance and validation tasks, technical expertise
Industry UsageUsed in pharmaceutical and biotech companies for leadership rolesCommonly found in quality assurance and compliance departments

The Associate Director Gxp typically holds a leadership position with strategic responsibilities, overseeing teams and ensuring compliance at a higher level. In contrast, the Senior Gxp Specialist focuses more on technical, hands-on compliance tasks. Both roles require similar credentials and are integral to Gxp operations, but they differ mainly in scope and level of responsibility.

What is an Associate Director GxP?

An Associate Director GxP is a senior professional responsible for overseeing compliance with GxP (Good Practice) regulations in areas such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) within pharmaceutical, biotechnology, or life sciences organizations. They ensure that processes, documentation, and operations meet regulatory requirements to guarantee product quality and patient safety. Their role often includes managing teams, conducting audits, developing policies, and collaborating with regulatory agencies. The Associate Director GxP plays a crucial part in maintaining the integrity of data and ensuring compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as an Associate Director GxP, and why are they important?

To thrive as an Associate Director GxP, you need in-depth knowledge of Good Practice (GxP) regulations, quality management systems, and a relevant scientific or pharmaceutical degree. Familiarity with regulatory compliance tools, audit management systems, and certifications such as Six Sigma or ASQ are often required. Strong leadership, problem-solving, and communication skills help manage cross-functional teams and ensure compliance across operations. These competencies are vital for maintaining regulatory standards, minimizing risks, and ensuring the integrity of clinical or manufacturing processes.

How does an Associate Director GxP typically collaborate with cross-functional teams to ensure regulatory compliance?

An Associate Director GxP frequently partners with Quality Assurance, Regulatory Affairs, Clinical Operations, and Manufacturing teams to uphold Good Practice (GxP) standards across the organization. This role involves leading compliance initiatives, facilitating audits and inspections, and coordinating the implementation of corrective actions. Effective communication and project management skills are essential, as the Associate Director must align diverse teams on regulatory expectations and best practices. Collaboration is often structured through regular meetings, shared documentation, and cross-functional training sessions.
Infographic showing various Associate Director Gxp job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 91% Full Time, 7% Part Time, and 1% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution.
Associate Director, Clinical Operations Capabilities & Performance Excellence

Associate Director, Clinical Operations Capabilities & Performance Excellence

AstraZeneca

Durham, NC • Hybrid

Other

Medical, Dental, Vision, Retirement, PTO

Posted 4 days ago


AstraZeneca rating

8.6

Company rating: 8.6 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

16th of 71 rated pharmaceutical


Job description

Location: Durham, NC Type: Hybrid (3 days in office, 2 days from home) The Associate Director, Clinical Operations Capabilities & Excellence serves as a strategic capability partner who operationalizes the capability and learning strategy for R&D Clinical Operations within a highly regulated GxP environment. This role translates strategic capability frameworks into actionable learning solutions, facilitates knowledge transfer and skill development, and ensures clinical teams across BioPharma and Oncology possess the competencies needed to deliver inspection-ready, efficient, and patient-centric trials. Working as an individual contributor with strong influencing skills, the Associate Director partners closely with functional leaders, subject matter experts, and cross-functional stakeholders to design, develop, and deliver modern, data-driven learning experiences that drive measurable business impact.

Accountabilities Strategy Operationalization: Translate the multi-year capability strategy into executable learning plans, curricula, and development pathways that align with R&D objectives and Clinical Operations priorities. Partner with the Director to operationalize capability frameworks, ensuring role-specific and role-agnostic competencies are embedded into practical learning solutions and development experiences. Support the implementation of annual learning roadmaps by defining detailed project plans, timelines, milestones, and success metrics for capability-building initiatives.

Collaborate with functional leaders across BioPharma and Oncology to understand specific capability gaps, business priorities, and learning needs, serving as their trusted capability partner. Learning Solution Design & Development: Design and develop education, exposure & experience (3E) focused solutions that incorporate adult learning principles, instructional design best practices, and modern learning methodologies (e.g., microlearning, social learning, experiential learning). Create blended learning experiences including eLearning modules, virtual instructor-led training, job aids, simulations, and on-the-job learning tools that support competency development

Ensure all learning content is aligned with internal SOPs and work instructions, maintaining strong linkages between process and training. Collaborate with the QMS Learning team and Learning Operations to ensure learning solutions are compliant, quality-assured, and integrated into appropriate learning systems and platforms. Curate and adapt external content and best practices to meet internal capability needs, ensuring cost-effectiveness and quality standards.

Facilitation & Knowledge Transfer: Design and facilitate interactive workshops, learning circles, communities of practice, and knowledge-sharing sessions that promote peer learning, collaboration, and capability development. Lead capability-building sessions for new hires, new-to-role transitions, and advanced skill development within the ClinOps capability framework. Serve as a subject matter liaison, connecting learners with experts and fostering networks that support continuous learning and knowledge exchange.

Coach and support functional leaders in embedding learning and development practices within their teams, promoting a culture of continuous improvement and learning. Continuous Improvement & Trend Analysis: Monitor internal performance data, learner feedback, and business outcomes to identify opportunities for learning solution optimization and capability enhancement. Stay current with external workforce trends, emerging learning technologies, industry best practices, and regulatory changes that impact Clinical Operations capabilities.

Synthesize trend insights and translate them into actionable recommendations for curriculum updates, new learning modalities, and capability roadmap adjustments. Contribute to learning effectiveness measurement by tracking completion rates, learner satisfaction, knowledge retention, and on-the-job application of skills. Stakeholder Collaboration & Partnership: Build and maintain strong collaborative relationships with Clinical Operations functional leaders, serving as their go-to capability partner for learning and development needs.

Influence stakeholders without direct authority, using data, insights, and compelling communication to gain buy-in and drive adoption of learning initiatives. Support change enablement efforts by partnering with change management teams to ensure smooth implementation of new capabilities, processes, and tools. Qualifications: Bachelor's degree in a relevant scientific/technical subject area, Learning & Development, Organizational Development, or related field; 7-10 years of progressive experience in learning & development, talent management, capability strategy, instructional design, or related fields Experience in pharmaceutical R&D or clinical operations environment strongly preferred; understanding of GxP and regulated environments highly valued Demonstrated expertise in adult learning principles, instructional design methodologies (e.g., ADDIE, SAM), and modern learning technologies Proven track record of designing and delivering effective learning solutions that drive measurable business outcomes and capability development Strong facilitation and presentation skills with the ability to engage diverse audiences and create interactive, learner-centered experiences Experience with learning needs analysis, competency framework development, and curriculum design Excellent collaboration and influencing skills with the ability to work effectively in a matrix environment and build partnerships across organizational boundaries Strong project management capabilities with the ability to manage multiple concurrent initiatives, prioritize effectively, and deliver results in a fast-paced environment Analytical mindset with experience using data and metrics to inform learning strategy and demonstrate impact Exceptional communication skills (written and verbal) with the ability to translate complex concepts into clear, actionable learning content Resourceful, self-directed, and outcome-focused with strong problem-solving abilities Experience working in global organizations across countries, cultures, and time zones The annual base pay for this position ranges from $129,031.20 - $193,546.80 Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours

Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer 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 included 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. Date Posted 01-Jun-2026 Closing Date 14-Jun-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.

In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.


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