Associate Director, Quality Assurance
Aurion Biotech · Centralia, WA
Job description(tap to read)
All Jobs > Associate Director, Quality Assurance Fully Remote • US Remote - WA, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS, IN applicants only DESCRIPTION JOB TITLE: Associate Director, Quality Assurance LOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS or WA. SALARY RANGE: $176,000 to $204,000 ABOUT THE POSITION This is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. As Associate Director, Quality Assurance, you will play a critical role in accomplishing this mission and in staging Aurion Biotech novel cell therapy treatment for successful launch in the United States. The Associate Director, Quality Assurance is responsible for overseeing activities performed by Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Labs (CTL) to ensure compliance against procedures and regulatory submissions and federal requirements. This position will also partner cross-functionally to strengthen quality systems, manage vendor quality activities, support inspection readiness, and foster a culture of quality and continuous improvement. KEY RESPONSIBILITIES • Serve as team lead to internal QA team members, leading QA oversight of CDMO and internal QA activities, ensuring compliance with regulatory/GMP expectations, and established Quality Agreements • Support and maintain vendor assessment activities • Quality management of vendors providing risk-based decision-making during manufacturing and testing activities • Support quality performance / continuous improvement activities • Oversee quality of third-party supplier's services (manufacturing, filling, packaging, shipping as appropriate) and maintain regular oversight via periodic monitoring, auditing, and Quality Agreement reviews • Manage Data Verification activities to ensure data integrity and compliance with GDP • Identify opportunities to improve quality systems and clinical-to-commercial operational processes and drive implementation to completion • Develop, monitor, and report meaningful quality metrics and KPIs to support Quality Management Review • Support Quality systems, including internal and external deviations and change controls • Assess product, compliance, or operational risks and partner with cross-functional teams to develop and implement effective risk management strategies • Review and approve controlled documents • Other duties as assigned ABOUT AURION BIOTECH With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company's first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan's PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values: • Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company. • Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate. • Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments. Aurion Biotech has a lot to accomplish in the next few years, and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com . LIFE AT AURION BIOTECH We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding: • Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO. • Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work. • Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values. Requirements QUALIFICATIONS AND EDUCATION To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Bachelor's degree Biology, Chemistry or other relevant scientific discipline preferred. • 8-10 years of cGMP Quality Assurance experience with cell therapy, biologics, and/or small molecule programs • 5+ years of experience in directly managing a team of direct reports within QA REQUIRED SKILLS AND ABILITIES • Travel required up to 35%. • Experience with eQMS (e.g., ACE, TrackWise) • Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company • Excellent record keeping and documentation skills • Strong communication skills, both verbal and written, with the ability to concisely present information in cross-functional settings • Experience working with CDMOs prefererd • Proficient use of MS Office products • Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met • Ability to work effectively both independently and with other team members. #J-18808-Ljbffr
Insurance Sales Representative - Work From Home
American Income Life - Giddens Organization · Abilene, TX
Benefits Representative 100% Virtual • 65,000-80,000 • 40 Hours per Week • Actively hiring Crafting Brighter Futures for Families At the forefront of specialized financial services, we help families safeguard their assets and promises a profound purpose: ensuring a brighter future for every client. Role Overview: As a Benefits Representative, you play a pivotal role in helping families protect their assets and secure their futures. You'll be the face of Globe Life, embodying our values and commitment. Primary Responsibilities: • Engage with clients to understand their financial goals and concerns. • Present tailored solutions to safeguard their assets effectively. • Maintain a pulse on the industry, ensuring you offer the best and most updated advice. • Foster relationships and ensure our clients always have someone they can turn to. Why Us? • Remote Work: Enjoy the flexibility of a full-time remote role. • Unlimited Earning Potential: Your dedication determines your earnings. • Company Culture: We're relaxed, high-energy, and treat every member like family. • Grow with Us: Dive into continuous learning and development opportunities. Application Process: 1. Submit Your Application: A hiring manager will review your application & resume and get back to you within 24 hours. 2. Schedule Company Overview: Select applicants will be contacted to schedule a position overview, detailing everything you need to know about the job details and your responsibilities. This 20-30 minute session is typically* done virtually for your convenience. 3. Interact with Us: During the overview, you'll have the chance to chat with our team members and ask any questions. Following the overview you'll be prompted to complete a brief assessment to gauge your understanding and compatibility with the position.
Benefits Representative - Work from Home
American Income Life - Giddens Organization · Slaton, TX
Benefits Representative 100% Virtual • 65,000-80,000 • 40 Hours per Week • Actively hiring Crafting Brighter Futures for Families At the forefront of specialized financial services, we help families safeguard their assets and promises a profound purpose: ensuring a brighter future for every client. Role Overview: As a Benefits Representative, you play a pivotal role in helping families protect their assets and secure their futures. You'll be the face of Globe Life, embodying our values and commitment. Primary Responsibilities: • Engage with clients to understand their financial goals and concerns. • Present tailored solutions to safeguard their assets effectively. • Maintain a pulse on the industry, ensuring you offer the best and most updated advice. • Foster relationships and ensure our clients always have someone they can turn to. Why Us? • Remote Work: Enjoy the flexibility of a full-time remote role. • Unlimited Earning Potential: Your dedication determines your earnings. • Company Culture: We're relaxed, high-energy, and treat every member like family. • Grow with Us: Dive into continuous learning and development opportunities. Application Process: 1. Submit Your Application: A hiring manager will review your application & resume and get back to you within 24 hours. 2. Schedule Company Overview: Select applicants will be contacted to schedule a position overview, detailing everything you need to know about the job details and your responsibilities. This 20-30 minute session is typically* done virtually for your convenience. 3. Interact with Us: During the overview, you'll have the chance to chat with our team members and ask any questions. Following the overview you'll be prompted to complete a brief assessment to gauge your understanding and compatibility with the position.
Entry Level Benefits Rep - Customer Service - Remote
American Income Life - Giddens Organization · Slaton, TX
Benefits Representative 100% Virtual • 65,000-80,000 • 40 Hours per Week • Actively hiring Crafting Brighter Futures for Families At the forefront of specialized financial services, we help families safeguard their assets and promises a profound purpose: ensuring a brighter future for every client. Role Overview: As a Benefits Representative, you play a pivotal role in helping families protect their assets and secure their futures. You'll be the face of Globe Life, embodying our values and commitment. Primary Responsibilities: • Engage with clients to understand their financial goals and concerns. • Present tailored solutions to safeguard their assets effectively. • Maintain a pulse on the industry, ensuring you offer the best and most updated advice. • Foster relationships and ensure our clients always have someone they can turn to. Why Us? • Remote Work: Enjoy the flexibility of a full-time remote role. • Unlimited Earning Potential: Your dedication determines your earnings. • Company Culture: We're relaxed, high-energy, and treat every member like family. • Grow with Us: Dive into continuous learning and development opportunities. Application Process: 1. Submit Your Application: A hiring manager will review your application & resume and get back to you within 24 hours. 2. Schedule Company Overview: Select applicants will be contacted to schedule a position overview, detailing everything you need to know about the job details and your responsibilities. This 20-30 minute session is typically* done virtually for your convenience. 3. Interact with Us: During the overview, you'll have the chance to chat with our team members and ask any questions. Following the overview you'll be prompted to complete a brief assessment to gauge your understanding and compatibility with the position.
Pediatric Behavioral Health Clinician
Cone Health · Eden, NC
The Behavioral Health Clinician provides team based behavioral health services and care coordination in the primary or specialty medical settings. The Behavioral Health Clinician provides a range of brief, solution-focused interventions for prevention, health promotion, and treatment of mental health, developmental, and psychosocial conditions to improve their ability to function. Working under close supervision, this role conducts psychosocial assessments and longer-term treatment plans if indicated. Essential Job Function: • Conducts brief, evidence-based and developmentally appropriate psychosocial assessments screening or other detailed assessments when indicated. • to better understand a patient's diagnosis, illness, or treatment through investigating emotional, social, and environmental factors. • Provides brief therapeutic interventions and supports the preparation and implementation of treatment plans to help patients return to optimal functioning. • Collaborates effectively as a member of an inter-disciplinary healthcare team that includes patients, their families, and other systems involved. • Assists health care team in crisis assessment and safety planning when behavioral health clinician is available during office hours. • Maintains knowledge of and relationships with community health and social agencies to expand the behavioral health services available to patients via collaboration or referral. • Educates the patient and family on behavioral health treatment care processes and options to inspire confidence and continue recovery once discharged. • Maintains accurate and timely documentation of patient care and treatment response plans in medical records to monitor recovery process. • Advocates for patients during the provision of care to manage potential ethical concerns or other risks. • Performs other duties as assigned. Education: • Required: Master's in social work, Mental Health Counseling, Psychology, or related fields. Experience: • Preferred: Experience working in a healthcare or mental health setting providing behavioral health interventions. Licensure/Certification/Listing: • Required: One or more of the following licensures: Licensed Clinical Social Worker (LCSW) or Licensed Clinical Social Worker Associate (LCSW-A), Licensed Clinical Mental Health Counselor (LCMHC), Licensed Clinical Mental Health Counselor Associate (LCMHC-A) License Clinical Addiction Specialist (LCAS), Licensed Clinical Addiction Specialist (LCAS), Licensed Marriage and Family Therapist (LMFT) or Licensed Psychologist (LP), or Licensed Psychologist Associate (LPA)BLS (CPR)-American Red Cross or AHA Healthcare Provider is required but waived if team member is 100% remote and does not meet in person with patients.