AbbVie Associate Director, Lead Process / Performance Standardization in Sunnyvale, California
Associate Director, Lead Process / Performance Standardization
Location: Sunnyvale, CA
# of Openings: 1
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE: ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
To learn more about us, please visit us athttp://www.pharmacyclics.com/
General Position Overview:
Lean, effective process management principles are critical to provide good management of clinical trials and sustained improvement to critical business processes. The Lead, Process and Performance Standards is responsible for overseeing, maintaining, and supporting the implementation of standards which enable efficient business processes and operational agility across Global Development Operations (GDO).
In collaboration with the GDO Leadership team, GDO Process Subject Matter Experts, and key stakeholders from other PCYC functions which interface with GDO on various processes, this role will define, manage, and monitor strategies and governance for the development, maintenance, deployment, and adoption of Process Standards through policies and business rules with a strong focus on compliance needs.
Key Accountabilities/Core Responsibilities:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Act as Process Owner of all Global Development Operations Processes
Define Controlled Documents Governance (i.e. create a Controlled Documents Governance Board/Charter)
Manage Controlled Documents Governance (i.e. facilitate reviews and approval process for all proposed SOP/WI, Forms, Templates, etc changes)
Partner with all process owners, internal and external to GDO, to ensure standardized updating and processing of controlled documents in MasterControl
Be single point of contact for GDO to manage communications with all internal and external stakeholders/process owners for change requests
Support process owners in developing of process performance metrics, reporting and improvement targets for all strategic business units
Drive improved business efficiency and quality through implementation of recognized best practices
Track industry and regulatory best practices to maintain high-level of standards
Align with GDO Training when new learning modules are needed because of process change(s)
Monitor internal and external audits of GDO processes as a means of assessing output of process improvement and initiate process revision(s), when needed
Master the requirements of the Pharmacyclics document control system, i.e., Master Control, for the handling and tracking of changed documents.
Champion ICH, E6 through process development which aligns GDO with cross functional partners to track and monitor Quality by Design from protocol development throughout clinical study execution and completion.
Drives culture change to instill focus on fact-based management practices, the use of Six Sigma and other problem-solving methodologies.
Identifies and eliminates or mitigates major COPQ (cost of poor quality) processes. Reduces defects with the goal of becoming defect-free
Continuously improves company’s organizational capabilities to achieve process quality as part of project execution, including an awareness of the need to “do it right the first time.”
Supports project teams in process quality activities by educating, coaching and mentoring others on process improvement philosophy, tools and application.
Business & Financial Acumen
Working Across Boundaries
Lean Sigma Methodology
Technical Capacity (e.g. Visio, MS products, CTMS)
Required Education and Experience
Bachelor/master’s degree in business administration (MBA) or bachelor/master’s degree in related field.
Minimum of 6 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (including 2+ years of direct quality/process management experience in drug development)
Minimum of 2 years leading drug development teams as a cross-functional project manager/process improvement expert
Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
Preferred Education and Experience
Broad knowledge of program management practices in the pharmaceutical industry
Oncology experience is preferred
Lean Sigma certification (Green or Black Belt certification and ability to become certified Master Black Belt).
Qualifications and Skills
Excellent communication, judgment, interpersonal and problem-solving skills
Strong organization and project management skills.
Excellent interpersonal and communication skills (both written and oral).
Ability to manage, drive, and execute projects from concept through implementation.
Ability to act as a change agent to instill a lean six sigma atmosphere and a continuous improvement culture.
Proven ability to effectively teach complex information across participants with experience and capabilities.
Proven ability to establish productive relationships and partnerships across the organization to ensure alignments of goals and deliverables.
Strong leadership skills, self-motivated, adaptable to a dynamic environment.
Ability to establish priorities, excellent sense of urgency and ability to collaborate (interpersonal, relationship management) with study teams, cross functional team members and external partners/vendors.
Must be proficient in taking initiative, have a hands-on approach and must demonstrate strong cross-functional facilitation skills to continuously drive improvement.
Ability to multitask and adapt to rapid change within a complex environment.
Self-motivated, adaptable to a dynamic environment.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled