Global Quality Manager
Location: Louisville, KY
Hourly rate: $44.00 - $54.00
Contractor benefits: Medical, Vision, Dental, 401k
Provide quality and compliance oversight for Clinical and Commercial PT distribution and in-country GMP/GDP operations to ensure they are suitable and effective to meet customer needs, regulatory requirements, industry trends and the company’s quality and compliance objectives.
Technical Job Responsibilities:
Manage required quality activities in the Clinical and Commercial PT distribution and in-country GMP/GDP operations owned by PT, including as applicable:
• Regulatory readiness activities required to ensure a regulatory compliant supply of clinical and commercial material, such as the quality oversight of Artworks operations; management of GMP documents required for Launches, Variations & Renewals and management of IMP Flowcharts required to ensure compliance to the respective IND/QIMPD.
• Quality oversight of Transportation activities including the management, resolution and Product Quality impact assessment of unplanned and planned events during transportation of clinical and commercial products.
• Quality oversight of Clinical and Commercial PT distribution and in-country GMP/GDP operations, taking place at Transport providers; Warehousing & distribution centers; Partners (including External Sponsors of Clinical Trials, In- / Out-Licensing Partners, Divestment Partners and Co-Promotion Partners); Local CMOs and Laboratories contracted for in-country testing activities.
• Customer engagement activities, including the intake and response to Customer complaints and the design and deployment of Customer-centric solutions applicable in the distribution operations.
• Own, manage and build Quality capabilities within the Distribution Quality Chapter and the Country Quality Network to meet Strategic Objectives, Customer’s expectations and promote a value-driven mindset.
• Identify and drive continuous improvements by actively scanning and keeping up to date on Customer’s needs and expectations, regulatory requirements and industry trends and network performance results.
• Ensure Audit and inspection readiness in the Clinical and Commercial PT distribution and in-country GMP/GDP operations.
• Own, manage and drive the implementation of Quality requirements applicable to Distribution in defined within PQS, and collaborate with external stakeholders to shape and evolve the corresponding regulatory requirements.
• Tasks required to enable the objectives described above are allocated fluidly depending on the needs, capabilities and capacity identified across individuals sharing the same responsibilities.
Functional Job Responsibilities:
• Collaborate and manage relationships across Clinical and Commercial Supply Chain, PD, the Country Quality Network and other PT stakeholders to ensure the suitability and effectiveness of Distribution Quality activities and cross-functional alignment on the intended outcomes.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.
• Sign documents as authorized and described by Roche policies, procedures and job descriptions.
• Be accountable for behaviors described in Roches Code of Conduct.
• Deliver business outcomes in support of departmental objectives.
• Maintain and communicate work priorities to meet goals and timelines.
• Timely complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.
• As applicable, deputize for the Regional Capability Leaders and peers and assist with their duties if and when required.
• May mentor and/or coach colleagues within and outside the organization.
• Contribute in organizational transformation activities to drive organizational effectiveness and increase the focus on customer needs.
Qualifications and Skills:
• 5 years of relevant work experience.
• Ideally, a B.A. or B.S. degree in life sciences or equivalent.
• Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience, ideally in Quality Assurance/Management or Supply Chain.
• Sound knowledge of current international Good Distribution/Manufacturing Practices and Quality Management ISO Standards.
• Highly competent in MS office or Google Suite applications.
• Strong knowledge of business systems that support processes (e.g. SAP, TrackWise).
• Demonstrated problem solving skills using methods and techniques, including Lean elements, to identify root causes and probable solutions.
• Demonstrated project management experience and outstanding customer focus.
• Experience leading cross-functional and international matrix teams is a plus.
• Ability to communicate clearly and professionally both in writing and verbally.
• This position may require up to 10% domestic and/or international travel.
• Onsite at the Kentucky Distribution Center.
Must be U.S. Person for purposes of Export Compliance.
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
