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Company: Kelly Services
Location: Gaithersburg, MD
Career Level: Mid-Senior Level
Industries: Recruitment Agency, Staffing, Job Board

Description

Quality Manager
Location: Gaithersburg, MD (60% onsite)
Pay rate: $53.00 - $60.00/ HR BOE


The Quality Manager is a key role in the Global Supply Team (GST) that provides brand aligned quality leadership across the E2E supply chain throughout the lifecycle of a brand as Supply Chain complexity is increasing.

This position requires strong cross-functional ways of working across the supply chain nodes, client Sites/Roles/Functions (PQL/GSC&S/GSM/Corporate Quality etc).

These individuals will manage multiple Brand Supply Chains (participate in more than one Global Supply Team).

The Quality Manager must possess capability in understanding impact of change, mitigating risks and responding to trends in Quality and supply chain principles, while embracing Modern Quality Professional (MQP) elements.

This includes, but is not limited to the following areas:

SUPPLY CHAIN DESIGN – Accountable for the Quality evaluation of supply chain design. This includes the development of Quality elements of the Supply Chain, mapping license structure across the Supply Chain and providing Quality Oversight to fulfil the MAH responsibilities.

QUALITY LEADERSHIP- Will lead a brand quality network to ensure appropriate escalation and collaborative resolution of Quality issues that may impact supply. Will support Issue Management Teams with a focus on Brand Quality Impact.

BRAND QUALITY RISK – Responsible to facilitate a Brand Quality Risk review, which considers the Quality Performance of both the product (Brand Health) and all nodes across the supply chain and provide any escalations into the Global Supply Team.

BRAND CHANGE – Will act as the Quality Approver on changes to the Supply Chain design and management, working collaboratively with colleagues across the brand network to implement changes and manage associated risks. They will also be responsible, with the Global Supply Team, to review the portfolio of changes across the Brand.

BRAND HEALTH – Will review a series of Brand specific Quality Metrics and share this performance with the Global Supply Team.

ALLIANCE/CUSTOMER QUALITY MANAGEMENT –Will act as the key Quality Contact for the Quality function in the customer organization, ensuring that communication and issue resolution is handled in accordance with an established Quality Assurance Agreement/Quality Framework.

In addition to the general description of the role, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this role:

  • Timely and efficient delivery of all Supply Chain quality aspects within their portfolio, Accountable for the quality evaluation of SC design and set up, whilst maintaining downstream visibility of timings and risk.
  • Quality Evaluation and approval of any non-standard supply for the brand (Including routine SAOC, One off Sales).
  • Responsible for Creation and Maintenance of Quality flow for Supply Chain Maps and associated master data.
  • Develops and maintains effective business relationships with Customers or Partners.
  • Accountable for Supply Chain QA decision-making (Design, Licence to Operate, Change, Risk, Flow); works directly with the GSSD/GBP, the Brand Quality Network and other GST team members to deliver objectives.
  • Support Business Development activities via Due Diligence and Deal Processes.
  • Acquire process and product knowledge for products supported.
  • Support the Global Supply Team. in the resolution of complex supply issues from a Quality perspective. Take the lead in escalated Quality issues. Support the delivery of optimized solutions and influence key stakeholders and decision makers across the network.
  • Provide Coaching and Mentoring on Quality Items to aligned Brand teams.
  • Work with Quality stakeholders via the Brand Quality Network to implement Global Supply Team strategies and escalate Quality constraints/Risks.
  • Leads Quality and Compliance with internal QCMs and external Regulatory requirements across the supply chain.
  • Supports the creation and maintenance of Quality SOPs and QCMs.
  • Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to Global Supply Team.
  • Responsible for Brand Quality Risk management and mitigation strategies.
  • Collaborates and influences, across the Brand Supply Chain team to facilitate process improvements with a focus on improving Quality.
  • Responsible for reporting and trending Brand Quality metrics and KPIs.
  • Drive a LEAN culture through active participation in Continuous Improvement/Practical Problem Solving, Product Supply Chain Strategy Plan, Business Continuity Planning, and Value Stream Mapping.
  • Model Modern Quality Professional behaviors with all Global Supply Chain activities.
  • Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role. Report potential issues of non-compliance.
  • Responsible for all Quality related deliverables to the Global Supply Team.
  • Holistic understanding of supply chain design and management.
  • Manage conflict and confidently stand alone on issues when necessary.
  • Propose tactical, data-driven solutions to high-level strategic initiatives and complex product issues.
  • Support across the Brand Quality Network to drive teams towards identification of true root cause and appropriate CAPA/risk management.
Requirements
  • Bachelor's degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering or relevant experience
  • Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance
  • Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment including strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
  • At the highest level, demonstrated leadership capability and interpersonal skills to serve as the Quality leader for Brand Supply Chain(s)
  • Strong problem solving and negotiating/influencing skills. Ability to work independently and excellent oral and written communication skills are also required. As is demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)
  • Strong Quality background is important, a minimum of 5 years.

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.


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