Associate Director, Therapeutic Area Quality

4 weeks ago

Oklahoma City, Oklahoma, United States VetJobs Full time
Associate Director, Therapeutic Area Quality - Devens, MA Join to apply for the Associate Director, Therapeutic Area Quality - Devens, MA role at VetJobs
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . But working at Bristol Myers Squibb is anything but usual. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. Position Summary The Associate Director, Therapeutic Area Audit Strategy Lead will be mainly responsible for developing the TA audit strategy and overseeing the planning, conduct and reporting of internal and external audits of clinical trial investigator sites.
Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and process/systems, including for-cause and directed activities.
Provide input in the global audit plans based on identified signals/trends/risks/gaps.
Partner with Risk, Governance, Operations (RGO) in the development of the Quality Narrative, specifically developing and contribution the audit/inspection portion.
Apply a risk-based approach to audit planning and execution.
Participate in audits and inspections, where needed, based on experience and resource availability.
Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities and RGO.
Translate risk factors into Clinical Quality Assurance oversight plans, including internal and external audit strategies and inspection readiness/management strategies.
Contact with appropriate technical, supervisory and management personnel internally and externally (BMS sites, vendors, partners etc.) Establish strong partnership with business stakeholders.
External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.
Other Responsibilities Lead multidisciplinary or cross-functional work/project teams; Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.
S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance
Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance.
In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management.
Extensive experience in regulatory inspection preparation, management, and related follow-up.
Demonstrated analytical and conceptual capability—including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data.
Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.

  • Director of Therapeutic Area Strategy

    2 weeks ago

    Oklahoma City, Oklahoma, United States Lensa Full time

    The Director, Medical Strategy (Prostate Cancer) will play a vital role in developing the strategic direction and alliance management for the Prostate Cancer therapeutic area. This role will set the strategy for both internal company programs and external facing interactions, leading and communicating with cross-functional team members to develop and execute...

  • Associate Director, Quality Risk Specialist

    4 weeks ago

    Oklahoma City, Oklahoma, United States VetJobs Full time

    Associate Director, Quality Risk Specialist - Devens, MA Join to apply for the Associate Director, Quality Risk Specialist - Devens, MA role at VetJobs . Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans,...

  • Associate Director, Quality Risk Specialist

    3 weeks ago

    Oklahoma City, Oklahoma, United States VetJobs Full time

    Associate Director, Quality Risk Specialist - Devens, MA Join to apply for the Associate Director, Quality Risk Specialist - Devens, MA role at VetJobs .Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans,...

  • Associate Director, Advertising and Promotion Compliance

    1 week ago

    Oklahoma City, Oklahoma, United States Gilead Sciences, Inc. Full time

    Gilead Sciences, Inc. is a leader in developing innovative treatments for patients worldwide. As an Associate Director, Regulatory Affairs Advertising and Promotion, you will play a critical role in ensuring the company's commercial activities are compliant with governing laws, regulations, and internal policies.Key Responsibilities:Manage the commercial...

  • Director of Medical Governance and Quality

    1 week ago

    Oklahoma City, Oklahoma, United States Gilead Sciences, Inc. Full time

    Director, Medical Affairs Research Policy & Governance At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to...

  • Director Quality

    1 week ago

    Oklahoma City, Oklahoma, United States INTEGRIS Health Full time

    The Director Quality and Safety is responsible for the development, management and evaluation of strategies, standards and programs addressing quality, patient safety and clinical performance. The Director executes programs focused on the delivery of safe, high quality healthcare and improved patient outcomes. INTEGRIS is an Equal Opportunity/Affirmative...

  • Associate Director of Quality Assurance

    2 weeks ago

    Oklahoma City, Oklahoma, United States ProtaGene US, Inc Full time

    Associate Director of Quality Assurance (GCP/GLP) Location: Burlington, Massachusetts, United States ProtaGene is a world-leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries. We provide advanced, integrated, and quality system-driven analytical capabilities, from research support through product CMC...

  • Director of Quality Excellence

    4 days ago

    Oklahoma City, Oklahoma, United States Nortek Data Center Cooling Full time

    The Director of Quality will lead a team of quality professionals in ensuring that our products and services meet the highest standards of quality and reliability. This role requires a strong understanding of quality management systems and processes, as well as the ability to collaborate with cross-functional teams to identify areas for improvement and drive...

  • Area Sales Director

    3 weeks ago

    Oklahoma City, Oklahoma, United States The N2 Company Full time

    As the nation's leader in helping small to mid-sized businesses connect with new movers and locals, The N2 Company produces high-quality monthly magazines, targeted digital advertising, online media, and creative events.We are seeking a new Area Sales Director for BeLocal Magazine to join our team. BeLocal magazines are the definitive community guide,...

  • Medical Director Pharmacy, Therapeutics,

    3 weeks ago

    Oklahoma City, Oklahoma, United States Highmark Health Full time

    Highmark Health Medical Director Pharmacy, Therapeutics, & Medication Safety in Oklahoma City, Oklahoma Company: Allegheny Health Network Job Description: GENERAL OVERVIEW: This role leads a Pharmacology & Therapeutics Committee and serves as a Medication Safety Champion. Reviews drug proposals, chairs meetings to determine formulary changes, and...

  • Governance and Quality Director, Medical Department

    1 week ago

    Oklahoma City, Oklahoma, United States Gilead Sciences, Inc. Full time

    Job Overview">The Director of Medical Affairs Policy and Governance at Gilead Sciences, Inc. is responsible for developing, revising, and implementing research procedural frameworks and cross-functional support for global and local medical affairs research across various therapeutic areas.">Key Responsibilities">">Develop and revise medical research...

  • Director of Quality

    6 days ago

    Oklahoma City, Oklahoma, United States Nortek Data Center Cooling Full time

    Position at Nortek Data Center Cooling Director of Quality - Data Center Cooling Maximize your potential. Minimize your footprint. Nortek Data Center Cooling is a Madison Industries company. Madison Industries is one of the largest and most successful privately held companies in the world and has a robust portfolio of indoor air quality solutions. Madison...

  • Therapeutic Services Specialist

    5 days ago

    Oklahoma City, Oklahoma, United States SSM Health Full time

    Therapeutic Services Specialist: As a Respiratory Therapist, you will play a crucial role in delivering high-quality respiratory care in a hospital setting. This position requires a unique blend of clinical expertise, compassion, and communication skills. Responsibilities: - Provide evaluation and care for patients requiring respiratory therapy - Assess...

  • Therapeutic Services Provider

    2 days ago

    Oklahoma City, Oklahoma, United States beBee Careers Full time

    Job Overview:">As a Therapeutic Services Provider, you will play a critical role in the delivery of high-quality patient care. Your primary responsibilities will include evaluating patient needs, developing personalized care plans, and administering prescribed therapeutic services.You will also be required to maintain equipment, respond to medical...

  • Quality Assurance Associate

    3 days ago

    Oklahoma City, Oklahoma, United States Mathis Brothers Full time

    Job Description:Mathis Brothers is seeking a highly skilled and detail-oriented Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will be responsible for ensuring the highest quality standards in our mattress manufacturing process.In this role, you will have the opportunity to work in a fast-paced production line environment...

  • Associate Medical Director

    3 weeks ago

    Oklahoma City, Oklahoma, United States Peak Recruiter Full time

    Valir PACE in Oklahoma City, OK is interested in adding an Associate Medical Director to their team.This is a wonderful opportunity for an up-and-coming physician interested in advancing their career in this quickly growing and evolving world of PACE (All inclusive Care for the Elderly).The Associate Medical Director collaborates with the Medical Director,...

  • Associate Medical Director

    12 hours ago

    Oklahoma City, Oklahoma, United States Peak Recruiter Full time

    Job Description Job Description Valir PACE in Oklahoma City, OK is interested in adding a Medical Director, and Associate Medical Director to their team. This is a wonderful opportunity for an up-and-coming physician interested in advancing their career in this quickly growing and evolving world of PACE (All inclusive Care for the Elderly) The Associate...

  • Director of Quality

    18 hours ago

    Oklahoma City, Oklahoma, United States CFS Brands Full time

    The Director of Quality will be responsible for leading and developing the company's quality assurance and quality control programs. This individual will oversee compliance with industry regulations, customer requirements, and internal quality standards while fostering a culture of continuous improvement. The Director will collaborate with cross-functional...

  • Therapeutic Radiation Professional

    2 days ago

    Oklahoma City, Oklahoma, United States beBee Careers Full time

    Therapeutic Radiation ProfessionalA Therapeutic Radiation Professional administers radiation therapy by exposing specific areas of the patient's body to prescribed doses of radiation. This role involves working closely with physicians and dosimetrists to ensure accurate positioning and delivery of treatment plans.You will also maintain patient records,...

  • Associate Medical Director

    3 days ago

    Oklahoma City, Oklahoma, United States Peak Recruiter Full time

    Valir PACE in Oklahoma City, OK is interested in adding a Medical Director, and  Associate Medical Director to their team.  This is a wonderful opportunity for an up-and-coming physician interested in advancing their career in this quickly growing and evolving world of PACE (All inclusive Care for the Elderly) The Associate Medical Director collaborates...