Overview:
What To Expect:
The Director of Quality provides leadership and strategic direction for the organizations quality programs to ensure policies and processes comply to produce high-quality safe products while promoting a process-driven environment that drives forward the vision and mission of the organization.
- Lead all functions of Quality Assurance, Quality Control, and Quality Systems, departments to prepare the company for growth in both domestic and international markets.
- Responsible for developing, executing, and managing the 1, 3, and 10-year strategic and tactical plans in alignment with company LTOs and determining capital investment priorities and budgets to maximize initiative's ROI.
- Oversees all communication and compliance with FDA and international regulatory bodies, acting as the key contact with external auditors and FDA investigators.
- Accountable for developing, benchmarking, and improving appropriate KPI metrics to demonstrate the effectiveness of the quality and regulatory programs.
- Analyzes, evaluates, resolves, and presents information relating to CAPA, OOS, quality, or regulatory concerns, including customer complaints, to members of the executive and leadership team.
- Maintain a high awareness of emerging regulatory issues, innovations, and industry standards to strategically meet and anticipate future business needs and objectives.
- Documents all quality and regulatory SOPs, policies, and accountability matrix to ensure standard work process continuously improve.
- Trains employees on cGMP and SOP compliance.
- Leads KASH development of staff skills consistent with business career ladder and staff passions.
- Assesses both suppliers' and own company's product specifications and customer requirements. Establish quality requirements of external suppliers; conduct or oversee supplier qualification audits.
What You Will Contribute:
- Bachelors Degree in Life Sciences or medically related field or equivalent combination of experience.
- At least five (5) years of experience in leading Quality and/or Regulatory teams
- Strong knowledge of FDA regulations and processes 21CFR100, 111, and 117
- Must show commitment to results, good judgment, teamwork, process improvement, and strong interpersonal skills.
- Excellent oral and written communication and presentation skills for interacting with senior leaders and employees
What You Will Receive:
- Competitive Compensation
- Bonus Program
- Health, HSA, Dental, and Vision Insurance: Comprehensive coverage to meet your needs.
- Life Insurance (company provided): Ensuring peace of mind for you and your loved ones.
- 401(k) Plan: With company matching to help you plan for the future.
- Health Savings Account (HSA): With company contributions to support your healthcare expenses.
- Paid Time Off: Start with 15 days of immediate PTO annually.
- Paid Holidays: Enjoy time off for recognized holidays.
- On-Site Wellness Meals: Company-paid meals to support your health.
- Gym Membership Reimbursement: Encouraging your fitness and well-being.
- Employee Assistance Program (EAP): Access to confidential support services.
- Voluntary Benefits: Options including short-term disability, life insurance (whole/term), hospital indemnity, critical illness, and accident expense coverage.
- Growth and Development Opportunities: Access to company university and tuition reimbursement programs.
- On-Staff Health Coach: Personalized coaching available one-on-one or in groups.
- Health and Wellness Initiatives: Participate in walking challenges, weight loss programs, health risk assessments, and more!
Why Work at Ortho Molecular Products:
Our healthcare system faces significant challenges, with issues like complexity and inefficiency. At Ortho Molecular Products, our vision is to help transform the practice of medicine. We work tirelessly to assist healthcare providers in adopting improved solutions for health issues, integrating lifestyle medicine and evidence-based nutritional therapies that enhance patient outcomes. Our commitment involves crafting scientifically grounded products and pioneering innovative clinical initiatives tailored to support doctors in supporting their patients' recovery and well-being.
We are looking for people who align with our mission and want to invest their lifework and passion into transforming the practice of medicine. Our team is purpose-driven, values-based, and service-focused. We are looking for likeminded people who want to join the movement that is changing the way healthcare is being delivered.
Ortho Molecular Products is an Equal Opportunity Employer.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
We invite you to explore the Ortho website to learn about our career opportunities and apply (www.orthomolecularproducts.com).
Join us in our mission to revolutionize healthcare and empower clinicians to make a difference!