Pharmacyclics, an AbbVie Company, based in Sunnyvale, CA represents the single largest acquisition AbbVie has ever made, and is key to AbbVie’s corporate strategy to add another very significant growth platform and diversification. Pharmacyclics will be run as a semi-autonomous, fully integrated operating unit of AbbVie, with all functions including among others Commercial, R&D and Manufacturing. The integration into AbbVie should be minimally disruptive for Pharmacyclics; hence the identity, structures and relative independence will be minimally adapted at this time. The new President of Pharmacyclics is Erik von Borcke, currently a senior executive with AbbVie who has relocated to the Sunnyvale Area and reports to the Chairman and CEO of AbbVie, Rick Gonzalez.
General Position Summary: The Senior Clinical QA Specialist supports the Clinical Quality Assurance (CQA) management in developing its clinical quality systems/procedures and ensuring quality oversight. Activities will cover all aspects of clinical studies and will require a focus on Good Clinical Practice (GCP) , Good Laboratory Practice (GLP), Pharmacovigilance (PV) regulations and guidances. Key Accountabilities/Core Job Responsibilities: • Contribute to strategic Clinical QA planning and risk assessment • Develop CQA plans and implements the actions necessary to ensure clinical trials are conducted in accordance with the audit plan, GCP guidelines and regulatory requirements • Lead and co-audit US and international sites, internal/external systems and vendors • Ensure all audits are followed-up and corrective actions are completed, implemented, and verified • Conduct investigations of GCP-related issues (i.e., product complaints) and develop corrective action plans • Manage CQA quality systems and support department infrastructure development; assist with creation/revision of appropriate CQA SOPs • Provide GCP guidance to internal departments for all phases of clinical drug development • Promote/advance quality awareness throughout the organization; coordinate and provide GCP training • Work in collaboration with clinical sites, Clinical Operations, Regulatory Affairs and other stakeholders to ensure compliance with GCPs and to maintain inspection readiness • Review regulatory submission documents (Clinical Study Report and Integrated Safety/Efficacy Summaries) and other essential documents (Protocol, Informed Consent Form, and Trial Master Files) • Develop metric reports for CQA management of all issues related to the outcome of the audits • Participate and represent CQA in clinical team meetings and discussions as needed
Education Requirements: • Minimum BA/BS degree preferably in biological sciences, pharmacy, or related field Experience: • 5+ years of pharmaceutical experience, preferably in Quality Assurance or a clinical setting • 1+ years direct US and international Clinical QA auditing experience, preferably with GLP/ PV QA experience Specific Skills/Abilities: • Excellent working knowledge of GCP-related requirements, proficiency of regulatory and ICH guidelines • Broad experience in the pharmaceutical industry with a strong clinical development background • Detail oriented with Quality Assurance and/or Clinical Development background with analytical and problem solving skills • Ability to work effectively in a fast-paced environment with initiative and great organization skills • Ability to analyze and reconcile moderate-to-complex GCP compliance issues independently and in a group setting • Experience with GLP and PV QA a plus • Must be a team player • Excellent verbal/written communication and interpersonal skills
An AbbVie Company
Every day, too many people miss out on the beauty and richness of life: A morning cup of coffee, reading to a grandchild, noticing a neighbor’s garden while out for a walk. These are treasures when someone has the strength, vitality, and opportunity to enjoy them. However, to a person dealing with life-threatening illness, opportunities like these can be erased ...by the overwhelming struggle to regain health and hold on to hope.
At Pharmacyclics, our every effort is directed to bringing new therapies to life: treatments that help people return to the lives they love as quickly and easily as possible. We believe there is nothing more powerful than giving back in this way. We believe there is nothing more valuable than turning hope into reality and allowing people to focus on the splendor in every day. This is what we call the magic of normal—and we want this for as many people as possible.
WHO WE ARE
We are the visionaries and innovators who believe anything is possible and we are not afraid to reach for the stars even when others see only darkness. We are changing the story for people impacted by cancer and immune-mediated inflammatory diseases. We are true allies of patients and caregivers who face serious unmet medical needs. We uphold our commitment through an unwavering determination to provide transformative medicines whose safety, efficacy, and tolerability outweigh their risks. We do this not because it is easy but because it is right, and because helping others is integral to what we believe.
Let’s take a walk together. In this episode, I am going to give you seven steps that you could use to get super focused on your career growth including where you want to go in your career. I will also explain to you how to track your progress in your engineering career. (The recording of […]