Job Description Business: Pharma Solutions
Department: Analytical Quality Control
Location: Lexington
Job Overview Reporting to the Director of Quality, the Sr. Manager, Analytical Quality Control ("AQC") has responsibility for the Analytical Quality Control AQC laboratories. The position will provide strategic direction and leadership to improve quality, efficiency and capability.
Reporting Structure This position reports to the Director of Quality
Key Responsibilities: - Direct oversight of activities performed within Quality Control Laboratories
- Monitor revenue goals ensuring that Laboratories meet or exceed expectations
- Develop and manage department budgets
- Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operations
- Establish short and long-range plans for the timely and efficient execution of the testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)
- Apply necessary oversight to the stability study program and ensure current regulatory guidelines are followed
- Oversee laboratory instrumentation activities including procurement, qualification, preventative maintenance, and calibration
- Establish, implement, and manage Laboratory Programs and/or Policies, SOPs, and good record keeping practices that are compliant with current regulatory requirements
- Oversee all quality investigations within the departments (deviations, CAPA and LIR)
- Ensure Lab Sustain Permanent Inspection Readiness (PIR)
- Ensure suitable laboratory safety procedures are in place
- Ensure that there is a department training program in place so that department staff are continuously developing and are current with industry practice
- Ensure that department technical expertise and capabilities are constantly evolving and current with industry.
- Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries
- Analyze and trend sample results and perform statistical studies and evaluations of key performance indicators
- Develop mechanisms and structures to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs.
- Encourage an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safety
- Lead and mentor individual group members
- Assign department resources so that company goals/timelines are achieved
QUALIFICATIONS: - B.A. or B.S in scientific related field, Biology, Life Science, Chemistry, or related scientific discipline preferred
- Minimum of ten (10) years' progressive experience in a regulated cGMP industry is required, with five (5) years' management experience
- Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
- Strong/demonstrated knowledge of cGMP regulations
- Possess excellent technical writing and oral communication skills
- Six Sigma Green Belt, Benchmarking and Project Management experience preferred
About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About the Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
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