Job title: Global Quality Manager Duration: 12 months Location: Louisville, KY
Main Purpose of the Position 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 & 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, Customers’ expectations and promote a value-driven mindset.
Identify and drive continuous improvements by actively scanning and keeping up to date on customers’ 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 thecorresponding 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 client policies, procedures and job descriptions.
Be accountable for behaviors described in client’s 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.
. Fluency in oral and written English is a must
. This position may require up to 10% domestic and/or international travel
Onsite at the Kentucky Distribution Center
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $42.00/hr.
