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Senior Director, 503B Outsourcing

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Pharmacy degree from an accredited school., Master's in healthcare related field preferred., Seven years experience required., Three years in direct leadership..

Key responsabilities:

Oversee day-to-day operations of the facility.
Ensure compliance with FDA and DEA regulations.

SSM Health XLarge https://www.ssmhealth.com/

10001 Employees

See more SSM Health offers

Job description

It's more than a career, it's a calling

MO-SSM Health Cardinal Glennon Children's Hospital

Worker Type:

Regular

Job Highlights:

Named 150 Top Places to Work in Healthcare 2023 - Becker's Healthcare

Named One of America's Greatest Workplaces for Diversity 2023 - Newsweek

Named One of America's Greatest Workplaces for Women 2023 - Newsweek

SSM Health is a Catholic, not-for-profit health system serving the comprehensive health needs of communities across the Midwest through a robust and fully integrated health care delivery system. The organization’s 40,000 team members and more than 12,800 providers are committed to providing exceptional health care services and revealing God’s healing presence to everyone they serve.

With care delivery sites in Illinois, Missouri, Oklahoma and Wisconsin, SSM Health includes 23 hospitals, more than 300 physician offices and other outpatient and virtual care services, 13 post-acute facilities, comprehensive home care and hospice services, a pharmacy benefit company, a health insurance company and an accountable care organization. It is one of the largest employers in every community it serves.

To request additional information, confidentially submit your interest, or nominate a fellow colleague, please contact:

Jon Dirksen

Executive Talent Acquisition

jon.dirksen@ssmhealth.com

#LI-Onsite

SSM Health is committed to equal employment opportunity based on race, color, religion, national origin, gender, sexual orientation, gender identity, pregnancy, age, physical or mental disability, veteran status, and all other statuses protected by law.

Job Summary:

Responsible for overseeing and managing the day-to-day operations at the 503B outsourcing facility. Ensures site operations and processes are integrated and meet US Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), US Pharmacopeia (USP), Board of Pharmacy requirements and industry best practices. Provides leadership in assuring department alignment in achieving organizational expectations of employee engagement, distinctive patient services, provision of quality and safe services, strategic planning, and fiscal responsibility. Acts as a communicator, facilitator, and translator of the organizational expectations. Ensures managers and staff have the human and fiscal resources to effectively accomplish an engaged workforce, distinctive patient services and the provisions of quality and safe services.

This is NOT a remote opportunity. This role will require relocation to St. Louis, MO upon acceptance of the role.

Job Responsibilities and Requirements:

PRIMARY RESPONSIBILITIES

Develops, implements, and monitors day-to-day operational systems and processes to provide visibility into the goals, progress, and obstacles of key initiatives.
Plans, monitors, and analyzes key metrics for day-to-day operations to ensure efficient and timely completion of tasks.
Manages various projects related to 503B processes and implementations.
Collaborates with executive-level management in the development of performance goals and long-term operational plan.
Analyzes market trends for preparation of the production schedule.
Sets strategic goals for operational efficiency and increased productivity. Monitors workload statistics to ensure appropriate staffing levels.
Implements long-term plans for facility growth, equipment, materials, technology, and workforce resources to maintain manufacturing capacity and processes.
Maintains the facility in a constant state of inspection readiness. Ensures staff are compliant with the Food and Drug Administration’s current good manufacturing Practice (cGMP) regulations and related elements such as facilities, training, reports, records, and documentation (e.g., standard operating procedures, validation protocols, etc.).
Responsible to oversee compliance with US Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Boards of Pharmacy regulations as they relate to Section 503B of the Food, Drug and Cosmetic Act (FDCA).
Recruits, engages, develops, leads, and manages assigned staff. 
Works in a constant state of alertness and safe manner.
Performs other duties as assigned.

EDUCATION

Pharmacy degree (Pharm.D; Bachelor of Pharmacy) from an accredited school of pharmacy
Master’s degree in healthcare related field (such as Healthcare Administration, MS or MBA) or equivalent experience

EXPERIENCE

Seven years' experience, with three years' in direct people management/leadership

PHYSICAL REQUIREMENTS

Frequent lifting/carrying and pushing/pulling objects weighing 0-25 lbs.
Frequent sitting, standing, walking, reaching and repetitive foot/leg and hand/arm movements.
Frequent use of vision and depth perception for distances near (20 inches or less) and far (20 feet or more) and to identify and distinguish colors.
Frequent use of hearing and speech to share information through oral communication. Ability to hear alarms, malfunctioning machinery, etc.
Frequent keyboard use/data entry.
Occasional bending, stooping, kneeling, squatting, twisting and gripping.
Occasional lifting/carrying and pushing/pulling objects weighing 25-50 lbs.
Rare climbing.

Work Shift:

Day Shift (United States of America)

Job Type:

Employee

Department:

3955000214 Pharm 503B Outsourcing

Scheduled Weekly Hours:

SSM Health is an equal opportunity employer. SSM Health does not discriminate on the basis of race, color, religion, national origin, age, disability, sex, sexual orientation, gender identity, pregnancy, veteran status, or any other characteristic protected by applicable law. Click here to learn more.