Vice President of Quality

7 days ago


Brighton, United States Bryllan LLC Full time

Are you interested in an exciting and rewarding career within a growing company? Are you motivated to collaborate with a team to achieve goals? Do you have passion for improving the lives of others?Bryllan is looking for respectful, empathetic, courageous individuals who are eager to utilize their skills in a rewarding career. Bring the knowledge and experience you've gained from your education and career, along with passion to proactively develop, lead, and drive the execution of the Quality Assurance and Regulatory Affairs program in the pharmaceutical manufacturing industry. Bryllan LLC in Brighton, Michigan, is a contract manufacturing organization (CMO) with a focus in sterile injectable pharmaceuticals. Bryllan embraces a management philosophy built around the principles of Quality, Integrity, and Service. If you feel invigorated by the thought of contributing to the creation of life enhancing or lifesaving products, this opportunity could be for youBryllan LLC is privately owned, rapidly growing Contract Manufacturing Organization that has designed a unique sterile filling and containment platform for multi-product filling of wide range of drug products and containers. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Bryllan is committed to Quality and is obligated to be compliant in support of our customers. We are currently searching for a dynamic Vice President of Quality and Regulatory Affairs to join our senior management operating team. The Vice President of Quality and Regulatory will proactively develop, lead, and drive the execution of the Company's assurance and regulatory strategy from early stages through to commercial scale manufacturing in line with customer need and capacity expansion, balancing the business needs with regulatory compliance. Overall responsibility for leading the corporate product quality systems, including the setting of quality goals, managing, and improving all aspects of the quality system and product quality with an emphasis on customer products and expectations. The Vice President of Quality will Serve as a key and active member of the Senior Leadership team to ensure that Quality and Regulatory objectives are a key focus of the company's goals.Essential Duties and Responsibilities:Quality Assurance & ComplianceServes as an active member of the Leadership Team responsible for development and setting of company Quality and Quality-related strategy and goalsAssures Bryllan gains site regulatory approvalProvides leadership and direction to the Quality organizationProvides mentorship, oversight and development for the Quality Assurance, Quality Systems and Quality Control staffHolds final accountability for and decision-making on the matters relating to quality and compliance for the companyMakes decisions focused on key quality- strategic and operational matters that have significant, direction-setting impact on the overall companyDirects and controls the activities and outcomes of Quality Assurance which has a significant organizational and product impactSets and aligns goals and objectives for the Quality Assurance department with the overall corporate goals and objectivesEnsures that the quality-related goals and objectives are accomplishedAccountable for Quality Assurance departmental staffing and must be comfortable supervising and operating in a virtual organizationProvides advice to the Leadership Team on regulatory compliance issuesServes as the principal spokesman with customers, regulatory agencies, etc., on matters of regulatory complianceWorks with all Bryllan employees to align and integrate the quality management system in all operational activityAccountable for vendor adherence to all applicable quality regulationsRegulatory AffairsProvide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide.Provide counsel, training and interpretation of FDA and other regulatory requirements to all company personnel.Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies.Develop and maintain external relationships with key opinion leaders, medical directors, and regulatory officials.Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events.Quality Control and MicrobiologyOversee the functions of the analytical and microbiology laboratory, including:Release of raw materials and componentsIn-process testingFinished product release testingEnvironmental MonitoringProvide leadership and direction for significant deviation events that may impact compliance status or significant business risk.Work Experience and Education RequirementsEducation & Experience: BA/BS undergraduate degree in life sciences, engineering, or business15+ years pharmaceutical quality, and regulatory and experience in a sterile manufacturing, CMO, or life sciences technology driven company. Extensive experience in cGMP and other Regulatory compliance requirements.Experience in strategic planning and collaboration with executive and key operational groups.Progressive & proven record of leadership and managing quality/regulatory/analytical organization's establishing long term strategic growth initiatives.Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization.Experienced in regulatory filings for NDAs/ANDAs/Mas and other regulatory filings.Required Knowledge, Skills & Abilities: High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.Excellent communications and presentation skills.Ability to develop and manage a high-performance team focused on accountability and meeting and exceeding Ability to lead, influence, create and work within cross-functional team environments.Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done.Success Metrics: Development and execution of Quality Assurance processes which assure site and product approvals.Execution of regulatory strategies which enable the company to achieve set objectives including product development, commercialization, and continuity of supply.With the Senior Operating team, ensure continual annual growth with corresponding profit.Preferred:M.B.A. or other relevant advanced degreePhysical Requirements:Ability to sit, stand and/or walk for no less than 8 hours a day.Ability to travel domestically and internationally via plane, train and car as required which is likely no less than 15%.


  • Mobile Veterinarian

    2 months ago


    Brighton, United States Lap of Love Full time

    Life is HAPPIER at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in BrightonCan you imagine working for a company that truly values its veterinarians and prioritizes your professional fulfillment and personal well-being? Established and owned by veterinarians, Lap of Love offers unparalleled professional freedom and a...

  • Mobile Veterinarian

    2 months ago


    Brighton, United States Lap of Love Full time

    Life is HAPPIER at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in BrightonCan you imagine working for a company that truly values its veterinarians and prioritizes your professional fulfillment and personal well-being? Established and owned by veterinarians, Lap of Love offers unparalleled professional freedom and a...


  • Brighton, United States Lap of Love Full time

    Life is HAPPIER at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in BrightonCan you imagine working for a company that truly values its veterinarians and prioritizes your professional fulfillment and personal well-being? Established and owned by veterinarians, Lap of Love offers unparalleled professional freedom and a...


  • Brighton, United States Lap of Love Full time

    Life is HAPPIER at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in BrightonCan you imagine working for a company that truly values its veterinarians and prioritizes your professional fulfillment and personal well-being? Established and owned by veterinarians, Lap of Love offers unparalleled professional freedom and a...


  • Brighton, Colorado, United States City of Brighton Full time

    Job OverviewThis role is responsible for providing critical support to victims of crime in the cities of Brighton, Commerce City, Fort Lupton, and Lochbuie. The ideal candidate will have a strong understanding of the criminal justice system and be able to provide advocacy services to individuals who have been affected by crime.Key Responsibilities:Respond to...


  • Brighton, Michigan, United States University of Michigan Full time

    Radiation Therapy Tech ARRT Job DescriptionAt the University of Michigan, we're seeking a skilled Radiation Therapy Tech ARRT to join our team in Brighton, MI. As a key member of our Radiation Oncology department, you'll play a critical role in delivering high-quality patient care.About the Role:Administer doses of radiation as prescribed by radiation...


  • Brighton, Michigan, United States YMCA of Greater Boston Full time

    Job SummaryWe are seeking a motivated and experienced Youth Program Coordinator to join our team at the YMCA of Greater Boston. This is a full-time position that will work closely with the Site Director to support daily After School Operations.ResponsibilitiesLeadership: Emphasize personal safety and emotional well-being with students, parents, and other...

  • Dental Assistant

    2 months ago


    Brighton, United States Family Dental of Thornton Full time

    Overview: Dental Assistant - $5,000! FAMILY DENTAL OF THORNTON a state-of-the art practice in Thornton,CO is looking for an experienced Dental Assistant to join our growing team. Our team is passionate about delivering the highest quality dental care to our patients. The ideal candidate should have experience that includes: Dentrix, implants, crowns,...


  • Brighton, United States YMCA of Greater Boston Full time

    At the YMCA of Greater Boston, we are seeking a highly experienced Aquatics Program Manager to oversee our competitive swimming program. This is a part-time position that requires exceptional leadership and coaching skills.**Salary:** $25-$35 per hourThis role is responsible for developing and implementing the competitive swimming program, ensuring quality...

  • Veterinarian

    7 days ago


    Brighton, United States Lap of Love Veterinary Hospice Full time

    Life is HAPPIER at Lap of Love Veterinary Hospice! Join Lap of Love as an In-Home, Associate Veterinarian in Brighton Can you imagine working for a company that truly values its veterinarians and prioritizes your professional fulfillment and personal well-being? Established and owned by veterinarians, Lap of Love offers unparalleled professional freedom and...


  • Brighton, Michigan, United States BrightStar Care of Novi, MI Full time

    Job OverviewBrightStar Care of Novi, MI is seeking a seasoned operations leader to oversee the delivery of high-quality home health care services. As the Director of Home Health Operations, you will be responsible for managing overall territory and office operations while maintaining accountability for all personnel.


  • Brighton, Colorado, United States Family Dental of Thornton Full time

    Seeking a part-time Dental Hygienist to join our team at Family Dental of Thornton in Thornton, CO. As an elite clinical provider and patient advocate, you'll receive best-in-class non-clinical support to provide exceptional lifetime patient care while obtaining unparalleled education to enhance your clinical skills.We're looking for a dedicated professional...


  • Brighton, Colorado, United States Family Dental of Thornton Full time

    Job OpportunityWe are seeking a skilled Dental Hygienist to join our team at Family Dental of Thornton in Thornton, CO.About the JobThis part-time position involves working Thursdays and/or Fridays, providing exceptional patient care and contributing to a dynamic oral health team.Salary and BenefitsThe estimated annual salary for this role is approximately...


  • Brighton, Michigan, United States Anesthesia Associates of Ann Arbor Full time

    About Anesthesia Associates of Ann Arbor">Our team at Anesthesia Associates of Ann Arbor is dedicated to delivering high-quality care in a state-of-the-art environment. We offer a comprehensive range of services, including orthopedics, endoscopy, cancer care, pain management, and general surgery.">Job Summary">We are seeking an experienced Anesthesiologist...

  • Lifeguard II

    1 month ago


    Brighton, United States YMCA of Greater Boston Full time

    Lifeguard IIDepartment: Aquatics Employment Type: Part Time Location: Oak Square YMCA Description Under the supervision of the Aquatics Director, this position is responsible for guarding the pool, ensuring the safety of all patrons, enforcing pool rules, and implementing the branch emergency protocols as needed. ESSENTIAL RESPONSIBILITIES/PRINCIPLE...


  • Brighton, Colorado, United States Family Dental of Thornton Full time

    OverviewDental Hygienist is required for a dynamic Part-Time position at Family Dental of Thornton in Thornton, CO. The ideal candidate will provide exceptional patient care while working in an environment that encourages full clinical autonomy.SalaryWe offer a competitive salary of $50,000 per year, which includes a $5,000 Sign on Bonus. In addition to your...

  • Dental Hygienist

    1 week ago


    Brighton, United States Family Dental of Thornton Full time

    $5,000 Sign on Bonus! Dental Hygienist Family Dental of Thornton in Thornton, CO is looking for a Part Time Dental Hygienist to join our team! Part Time: Thursdays and/or Fridays As an elite clinical provider and patient advocate, you'll receive best in class non-clinical support to provide exceptional lifetime patient care while obtaining...

  • Dental Assistant

    1 week ago


    Brighton, United States Family Dental of Thornton Full time

    Job Description$5,000 Sign on Bonus! Dental Hygienist Family Dental of Thornton in Thornton, CO is looking for a Part Time Dental Hygienist to join our team!Part Time: Thursdays and/or Fridays As an elite clinical provider and patient advocate, you’ll receive best in class non-clinical support to provide exceptional lifetime patient care while obtaining...


  • Brighton, Michigan, United States YMCA of Greater Boston Full time

    We are currently seeking a skilled and passionate Group Exercise Instructor to join our team at the YMCA of Greater Boston.About This RoleThis is an exciting opportunity for a qualified individual to lead engaging and effective group exercise classes, promoting physical fitness and well-being among our members.As a Group Exercise Instructor, you will be...


  • Brighton, Michigan, United States Closet Factory of Detroit Full time

    Unlock Your Potential as a Sales and Design ExpertCloset Factory of Detroit is a renowned leader in custom storage solutions, and we're seeking a highly skilled Sales and Design Consultant to join our team. As a key member of our organization, you'll play a vital role in delivering exceptional customer experiences and driving business growth.About the...