Senior Market Access Manager facilitating market access strategies and healthcare dynamics in China. Collaborating with stakeholders and providing insights into clinical and medical market access topics.
About the role
- Quality Control Manager ensuring compliance with cGMP regulations at Leiters Health. Leading quality control activities and managing QC associates in a 503B facility.
Responsibilities
- Responsible for drug preparation and supporting activities including: Lead and manage employees who are responsible for all quality control activities in a 503B facility, ensuring the required initial and continuing training of personnel is accurate or adapted according to need.
- Develop and maintain and ensure adherence to an appropriate staffing model to ensure that the QC unit is appropriately staffed to meet the demands of the business in an efficient and comprehensive manner based on the Company’s strategy, goals and objectives.
- Evaluate completed formulation records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria met.
- Review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended use.
- Approve and monitor analyses carried out under contract through 3 rd party private laboratories.
- Monitor the maintenance of the department(s) premises, processes and equipment.
- Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are completed and current.
- Investigate reprocessing/rework of products, complaints, analytical failures, deviations and OOS.
- Achieves quality operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
- Meets quality financial objectives by estimating requirements; assisting in the preparation of an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
- Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality control procedures.
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
- Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- Interact effectively with the Leadership Team and contribute to the continued growth and success of the Company through innovative thinking, planning, and implementation of new concepts, products and services.
- Professionally represent Company, including all relevant conferences and new customer segments.
- Work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control.
- Other duties as assigned.
Requirements
- Minimum of 5 years of experience working in an FDA-regulated environment, minimum of 3 years of management experience.
- Strategic and analytical thinker, with the ability to examine details and interpret the impact of key business drivers or potential adverse issues.
- Demonstrated knowledge and experience with US FDA cGMP, preferably in a commercial compounding outsourcing facility.
- Superior problem solving and decision-making skills.
- Team player with the ability to build relationships and work collaboratively across lines of senior leadership and other team members as appropriate.
- Knowledge of compounding techniques, controlled environments, and appropriate materials and conditions.
- Highest level of integrity and good judgement, with the ability to effectively deal with highly sensitive, confidential information.
- Demonstrated commitment to sound business ethics and corporate responsibility.
- Excellent organization as well as oral and written communication and documentation skills
- Detail oriented.
- BS or BA degree required (in a scientific discipline desired)
- Experience in a cGMP environment in manufacturing/laboratories with a preference for sterile compounding.
- Computer skills, including Microsoft Word and Excel.
- Able to lift up to 20 lbs and stand for up to two hours when required.
Benefits
- Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
- Flexible Spending & Health Savings Accounts (FSA & HSA) available
- Dental & Vision insurance
- Employer Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching (100% vested on day one!)
- Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
- $5,250 Annual Tuition Reimbursement after 6 months
- $1,000 Referral Bonus Program with no limit
- Eligible for annual bonus program
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