Distribution Quality Assurance Manager - Optum Specialty Distribution - Etna, OH

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Come make an impact on the communities we serve as we help advance health equity on a global scale. Here, you will find talented peers, comprehensive benefits, a culture guided by diversity and inclusion, career growth opportunities and your life's best work.(sm)

Optum is seeking a driven leader to fill the role of Distribution Quality Assurance Manager at a 300K sq. ft. distribution center located in Columbus (Etna), OH. The Distribution Quality Assurance Manager will be a key team member of an exciting new business serving patients with rare diseases, pharma manufacturers, and providers by distributing and servicing therapies at the frontier of healthcare. The successful candidate will be responsible for helping identify and maintain quality and regulatory standards for the distribution center to inform planning and future organizational design and growth. This role will report to the Facility Site Director.

This is an incredible opportunity to lead the quality, continuous improvement, and regulatory needs of the distribution facility. If you are passionate about inspiring, motivating and developing team members, this leadership opportunity could further enhance your career journey and we want to hear from you. You would have the unique opportunity to lead a team supporting operations creating a positive dynamic culture for your department and the entire DC, that reinforces our Optum values.

Delivering top-notch service to our customers while also achieving performance standards and metrics is a daily goal of this leadership role. Features within the DC such as automated induction, workflow management, pick to light, and automated storage retrieval systems facilitate meeting those goals. You will have the tools and resources in place to manage a highly successful team of employees. Initial travel throughout the network to other high volume DCs may be required to increase your knowledge of our business.

In this role, you will serve as a strategic partner for the distribution center business leader as you plan, lead, and coordinate quality and continuous improvement initiatives within the entire DC. You will strive towards operational excellence and quality. Leading internal quality audits and establishing/improving on standard operating processes will also be a key responsibility. Under the general direction of the Site Director, the Distribution Quality Assurance Manager will be responsible for developing the Quality program for Optum’s distribution business. They will develop and implement the processes (including SOPs) to ensure that Optum distribution locations operate in compliance with applicable quality regulations and practices and will provide strategic and operational leadership for planning, management, support and execution of quality activities for Optum distribution with a focus on controlled documentation, quality assurance, timely investigation of quality shortfalls, accountability of training, and inspection readiness.

This quality leader will work with internal training partners to establish a strong and exciting training program for all new hires while also implementing improvement initiatives for our existing team.

As a new Optum business, we are building on our strengths but also challenging the status quo. We are creating a business that is designed to specifically serve the unique needs of patient populations using Specialty Pharmacies and supports the opportunity for expansion into additional therapies, which require enhanced services and new capabilities over traditional specialty distributors.

Primary Responsibilities:

• Develop and implement Quality program(s) for Optum's specialty distribution business, including development of processes, policies and SOPs intended to ensure compliance with applicable quality regulations and practices (e.g. cGxP, cGDP, ISO, USP, 21 CFR, GS1, FDA and other applicable distribution industry standards and regulations)
• Define the process and provide ownership of a Quality Management System as well as Quality SOP creation, approval & implementation for distribution
• Promote a culture of quality & inspection ready status at the distribution centers with a focus on cGxP regulatory requirements
• Lead compliance with the applicable regulations, including DSCSA requirements for distribution centers
• Coordinating and overseeing initial and ongoing qualifications (IQ/OQ/PQ) and associated temperature mapping procedures for all pharmaceutical product storage areas
• Accountable for coordinating and overseeing the installation and ongoing maintenance of temperature and humidity monitoring equipment and excursion alarms for all pharmaceutical storage areas. This responsibility includes developing contingency plans to prevent product loss, in the event of an equipment failure
• In partnership with Optum transportation / engineering team(s), design and develop thermal/physical qualification of packaging systems that meet or exceed distribution SLA’s in accordance with industry accepted certification standards (ISTA, ETC.)
• Establish and maintain quality agreements with suppliers and service providers
• Lead team members in support of Optum Specialty Distribution quality initiatives
• Support compliance to both internal and external regulatory requirements (FDA/OSHA)
• Influence cross-functional teams within the DC to improve processes, quality, service, and productivity while reducing cost
• Coach and mentor team members on topics of quality and continuous improvement to increase employee engagement
• Provide support during change initiatives, and promote a culture of continuous improvement to all team members, at all levels
• Ensure initiatives are data driven, prioritized properly, and carried out timely
• Established data-driven quality metrics and goals
• Enhance customer satisfaction levels by leading investigations to determine root cause, establish preventive measures, and provide after action reports
• Apply Lean/Six Sigma tools and methodology to improve, solve problems and for re-engineering processes. Includes implementation and sustainment of 5S program, Kanban lanes, and other applicable methodologies
• Develop and manage a DC training program to improve efficiency and incorporate best practices
• Leading and supporting continuous improvement initiatives that improve customer care, reduces cost, improves service, capacity and productivity
• Implement & oversee the content, delivery & documentation of quality related training at distribution centers
• Support any related investigations and inspections for distribution centers
• Oversee and conduct the completion of periodic internal and external audits to ensure compliance with established quality related policies and procedures
• Analyze audit reporting regarding QA findings from internal and external distribution center audits to monitor & identify trends and areas of opportunity
• Develop metrics based on distribution center audits and investigations to identify continuous quality improvement opportunities and quarterly manager reviews
• Oversee the investigation and implementation of effective Corrective and Preventive Action (CAPA) program to prevent reoccurrence of quality & cGxP regulatory related concerns
• Support distribution centers to ensure VAWD criteria are met on an ongoing basis and recertification accreditation activities are completed in a timely manner

You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

• Bachelor's degree or equivalent work experience
• 5+ years operational and leadership experience
• 5+ years related progressively responsible experience with quality systems and QA operations in an FDA-regulated environment
• 5+ years of creation of processes, policies, and SOPs in quality
• Experience interacting with FDA/NABP/VAWD personnel during inspections
• Experience in the oversight of internal investigations, including managing closeout of investigation findings in a timely manner
• Experience with automation and workflow management systems
• Deep understanding of how all departments within a distribution center function and their interdependencies

Preferred Qualifications:

• 2+ years of experience in Pharma or Pharmaceutical Manufacturing
• Experience in continuous improvement
• Experience leading and influencing team members
• Experience proactively identifying issues, investigating issues to root cause, identifying alternative solutions and developing safeguards from event(s) occurring again
• Solid knowledge of lean sigma methodologies required (Six Sigma Black Belt preferred)
• Knowledge of applicable state and federal pharmaceutical distribution regulations
• Advanced computer skills including typical office suite programs
• Proven positive change leader with strong interpersonal skills

Physical Requirements

• General office and distribution demands
• Position includes standing, sitting, walking, carrying boxes in a warehouse environment

Competencies:

• Solid critical thinking skills with the ability to see the “big picture”
• Solid interpersonal skills; self-starter, lead teams, work with cross-functional groups
• Excellent verbal and written communication skills

Careers with OptumRx. We're one of the largest and most innovative pharmacy benefits managers in the US, serving more than 12 million people nationwide. Here you’ll fill far more than prescriptions. As a member of one of our pharmacy teams, you’re empowered to be your best and do whatever it takes to help each customer. You'll find unrivaled support and training as well as a wealth of growth and development opportunities driven by your performance and limited only by your imagination. Join us. There's no better place to help people live healthier lives while doing your life's best work.(sm)

California, Colorado, Connecticut, Nevada, New York City, or Washington Residents Only: The salary range for California, Colorado, Connecticut, Nevada, New York City, or Washington residents is $85,000 to $167,300. Pay is based on several factors including but not limited to education, work experience, certifications, etc. In addition to your salary, UnitedHealth Group offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with UnitedHealth Group, you’ll find a far-reaching choice of benefits and incentives.

*All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.

Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.

UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.