Associate Director, Corporate And Development Quality

Horizon Pharma Fort Collins , CO 80521

Posted 2 months ago

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

This position is responsible for playing a leading role in the quality operational activities for Horizon's pipeline of clinical and developmental candidates. Specifically, this position will be primarily responsible for Person In Plant (PIP) oversight of manufacturing activities related to drug development work. Duties include: quality representation, communication, and management of quality issues with internal partners, (e.g. technical operations, clinical operations, clinical supply, and R&D) and external partners (e.g. CMOs and 3rd party laboratories). Supporting, executing and leading quality operational, strategic and team goals for assigned product(s), as well as establishing strategic plans to optimize both team and company performance in order to assure the highest quality standards and regulatory compliance.

This position is a leading role responsible for the quality operational activities associated with Horizon's clinical and development programs. This position is responsible for ensuring the highest quality standards for the assigned product(s) by providing production oversight and release responsibility for the drug substance, drug product, and clinical packaging of assigned product(s). This person is responsible coordination or execution, as applicable, of QP release. This team member supports and serves as the analytical, technical, and quality operational expert for the assigned product(s) including combination products and/or devices.

Responsibilities, including but not limited to:

  • Lead quality for clinical and development product(s) to internal partners

  • QA oversight at CMOs and 3rd Party Labs

  • Oversight of in-process monitoring, investigations, change controls, CAPAs, and process validation

  • Lead and communicate risks to product, supply, clinical study subjects, or business, propose solutions, escalate and communicate in an appropriate and timely manner

  • Execution and support of vendor audits

  • Own preparation of materials for business reviews and routine operational meetings

  • Oversight of all product testing, methods, and investigations

  • Assurance of phase-appropriate method development, qualification, and validation

  • Execution of clinical product complaint handling, manufacturing investigations, tracking and corrective actions

  • Tracking and monitoring of quality control data

  • Tracking and monitoring of batch trending data

  • Assurance of safety, identity, and purity of assigned product(s)

  • Review of clinical/development batch documentation and clinical/development batch disposition

  • Coordination of QP release, as applicable

  • Key contributor to NDA, BLA, MAA, NDS, etc. preparation

  • Facilitate technical and knowledge transfer to commercial quality team

Qualifications and Skills Required:

  • BA/BS in Chemistry, Biology, or equivalent required

  • 10+ years pharmaceutical experience with at least 3 years in a QA/QC position supporting pharmaceutical production and/or testing

  • Experience with cell culture, biologic purification, parenteral fill/finish, and/or bioassay processes

  • Expertise in pharmaceutical product quality

  • Ability to work with high level contact and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment

  • Strong written and verbal communication skills

  • Ability to partner effectively with internal and external partners

  • Proficient in Microsoft Office

  • Professional demeanor

  • Self-starter attitude

  • Strong interpersonal skills

Horizon Core Values & Competencies:

Growth

  • Manages Ambiguity

  • Strategic Mindset

  • Demonstrates Self-awareness

  • Cultivates Innovation

  • Develops Talent

Accountability

  • Drives Results

  • Ensures Accountability

  • Decision Quality

Transparency

  • Courage

  • Collaboration

  • Instills Trust

Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Cultural Resource Specialist Afcec Environmental Quality Branch Jbsa San Antonio TX

Colorado State University

Posted 2 months ago

VIEW JOBS 10/1/2020 12:00:00 AM 2020-12-30T00:00 Working Title Cultural Resource Specialist - AFCEC Environmental Quality Branch, JBSA - San Antonio, TX Position Location San Antonio, TX Research Professional Position Yes Posting Number 202000753AP Position Type Admin Professional/ Research Professional Classification Title Research Associate IV Number of Vacancies 2 Work Hours/Week 40 Proposed Annual Salary Range $90,000 to $100,000 Desired Start Date 11/02/2020 Position End Date (if temporary) To ensure full consideration, applications must be received by 11:59pm (MT) on 10/19/2020 Description of Work Unit CEMML is a research, education and service unit within the Warner College of Natural Resources at Colorado State University (CSU). CEMML applies the latest and most appropriate science to promote the sustainable management of natural and cultural resources on Department of Defense (DoD) and other public lands. We provide technical support, conduct applied research, and offer career development and learning opportunities to support resource stewardship. We collaborate with our sponsors and within CSU to resolve complex environmental issues, leaving a legacy of science-based decisions that sustain our resources for future generations. To learn more about CEMML's contributions to land management, our mission, vision, and values, visit http://www.cemml.colostate.edu/. Position Summary A Cultural Resource Specialist position is being advertised with the Center for Environmental Management of Military Lands (CEMML) to provide technical, strategic, evaluation, and planning support and expertise in the areas of cultural resources management and tribal relations for the Air Force Civil Engineer Command (AFCEC) Environmental Quality Branch. This position is duty-stationed at Joint Base San Antonio (JBSA) and will provide on-site technical support to AFCEC subject matter expert (SME) and Subject Matter Specialists (SMSs) in the development of technical tools and guidance to support the Air Force Cultural Resources Program. Relocation expenses may be available; conditions apply. Temporary telework arrangements may be considered, but are subject to being modified or discontinued immediately upon written notice. The Cultural Resource Specialist will provide expert technical, policy, and planning advice to AFCEC SME and SMSs regarding strategic evaluation, planning, and implementation of current Executive Orders, as well as DoD, and U.S. Air Force mandated environmental goals and objectives. This may entail complex studies and analyses to evaluate adequacy and alignment of current and future efforts and activities that have implications for compliance with cultural resource statutes and regulations. The Cultural Resource Specialist may assist SME and SMSs in defining and describing policy options, including enterprise-wide environmental aspects and targets to improve program goals and objectives. This will entail consistent monitoring of DoD and Air Force initiatives related to cultural resource issues in order to provide informed analysis and advice to SME and SMSs. Other tasks may include, but are not limited to, developing recommendations for execution strategies and improvement to policies and guidance documents, including the Air Force Cultural Resources Management Playbook, Integrated Cultural Resources Management Plan (ICRMP) guidance documents, guidance governing government-to-government tribal relations and Installation Tribal Relations Plans (ITRPs), etc. Cultural Resource support tasks may also include briefings, presentations, and memoranda for AFCEC/CZTQ management deliberations and decisions; assisting with Air Force biannual environmental data call and the annual Environmental Management Review; evaluating and recommending improvements to evaluation metrics and Historic Facility Inventory data; as well as assisting with meeting coordination, drafting meeting materials and minutes, data consolidation, and developing Cultural Resources briefing slides. This is a 12-month Administrative Professional position with the possibility of extension for up to six years. Required Job Qualifications * MS/MA in anthropology/archaeology, history, architectural history, or closely related field with knowledge and experience in cultural resource management and historic preservation planning is required, plus 5 or more years of relevant experience. * Must meet the Secretary of the Interior's Professional Qualification Standards (36 CFR 61, Appendix A) to be considered. * Experience working in highly structured organizations such as governmental agencies, the military, or corporations with clearly established lines of authority, procedures, and protocols. * Prior experience conducting complex studies and analyses and presenting divergent professional cultural resource opinions. * Demonstrated knowledge working with U.S. federal historic preservation laws and regulations that govern federal historic preservation requirements and tribal consultation, and have demonstrated experience carrying out consultation and compliance activities under those regulations. * Experience consulting with the Advisory Council on Historic Preservation (ACHP) and State Historic Preservation Offices (SHPO). * Have a thorough understanding of most standard computer programs. * Excellent written communication skills. * Must have, or be able to obtain, a Department of Defense Common Access Card (CAC) and be eligible to obtain a Secret Clearance. * The successful candidate must be legally authorized to work in the United States by proposed start date. CEMML will not provide visa sponsorship for this position. * Must have a valid driver's license or the ability to obtain a driver's license by the employment start date. Preferred Job Qualifications * Demonstrated experience acting with diplomacy and discretion at all organizational levels, work with a wide range of information, organize details, and meet deadlines. * Experience supporting Regional- or Headquarters-level Cultural Resource programs. * Experience developing and providing program oversight and execution is helpful. * The most highly qualified candidates will demonstrate knowledge of cultural resource issues on U.S. military installations and extensive knowledge of Department of Defense and U.S. Air Force policies and processes related to cultural resources management, as gained through working for, or with, the Department of Defense. * Demonstrated knowledge and experience conducting consultation in support of federal historic preservation laws, regulations, and policies, including the National Historic Preservation Act (NHPA), National Environmental Policy Act (NEPA), Archaeological Resources and Protection Act (ARPA), Native American Graves and Repatriation Act (NAGPRA), and 36 CFR 800. * A high degree of analytic acumen, initiative, and resourcefulness; proven leadership skills and team-building capabilities; and excellent oral and written communication skills are desirable. * Previous experience writing high-level briefing packages suitable for presentation to military leaders is highly desirable. * Experience with IWIMS, ACES or TRIRIGA; Air Force eDash; and/or other DoD databases; as well as SharePoint systems is beneficial. * Current Secret clearance or clearance within the last 10 years is also beneficial. Diversity Statement Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department's commitment to diversity and inclusion. Colorado State University Fort Collins CO

Associate Director, Corporate And Development Quality

Horizon Pharma