12 days old

Senior Manager of Quality Assurance - IVD

Kelly Services
Gaithersburg, MD 20898
**Sr. Manager, Quality Assurance**

Our 200+ employees operate FDA-registered and ISO 13485-accredited facilities in across several locations within the U.S. and support diagnostic professionals in laboratories across the globe. We partner with IVD manufacturers, pharmaceutical, CRO, and academic institutions to share our expertise and resources in clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics.

We are committed to improving patient healthcare by offering products and services that support accurate and reliable diagnostic results.

**Job Purpose**

Working with and reporting to the VP, Quality & Regulatory, the Sr. Manager, Quality Assurance will support the LGC Clinical Diagnostics BU purpose of Science for a Safer World. As the Sr. Manager, Quality Assurance, this leader will manage and enable high-functioning operational quality assurance and document control teams which continuously contribute to the improvement of LGC Clinical Diagnostics BU Quality Management System processes, including assuring quality and customer standards and appropriate final product dispositions, managing LGC Clinical Diagnostics BU document flow, training, supplier, and feedback processes. This position will provide clearly articulated goals and priorities and needed support to the team, as well as be an individual contributor to the teams workflow as needed to meet internal and external customer needs and regulatory requirements.

**Key Responsibilities**

+ Proactively communicate upward and cross-functionally with colleagues in order to build relationships throughout the organization to develop a high-performance team with clearly articulated goals and priorities, with adequate resources and departmental partnerships.

+ Be knowledgeable in LGC Clinical Diagnostics BU products and processes in order to have the capability to contribute to and lead activities related to quality team functions.

+ Ensure valid inspection and testing of specialty human blood products, disease state and other biological materials, ensuring corporate standardization in compliance with FDA, USDA, ISO, IVD Directive, and MDSAP requirements, creating tools for inspection guidance.

+ Maintain a robust company-wide document control function and systems, ensuring the effective management, control, and availability of controlled documents utilized by all functions of the organization.

+ Manage timely closure of complaints and determination of additional actions, including CAPA and vigilance activities.

+ Maintain robust company-wide training program including identification of appropriate training roles, methods for competency assessment, and records management.

+ Coordinate and participate in regulatory audits, customer audits, and internal audits for best product outcomes.

+ Maintain the supplier management program including supplier monitoring and auditing activities.

+ Provide Quality Assurance support to new product development activities.

+ Identify risk and evaluate deficiencies while working with internal departments to appropriately remedy them.

+ Maintain an in-depth understanding of the quality and regulatory environment and specific operational details related to Quality System activities.

+ Coordinate, lead, and report at multi-site QRB (Quality Review Board).

+ Perform and coordinate batch record review and release for serology, molecular, and clinical genomics products.

+ Issue, review, and approve NCMRs and deviations and participate in root cause analysis.

+ Serve as the MD site Quality Management Representative.

**Knowledge, Experience and Technical Skills**

+ Exceptional leadership talent with ability to develop and motivate team through clear articulation of priorities, goals, and processes and through modelling best practices and providing support.

+ Possesses strong management and organizational skills with ability to project manage in order to meet deadlines, solve problems, focus on priorities, and communicate effectively with all stakeholders.

+ Able to work independently and deal with ambiguity by actively seeking clarification and understanding.

+ Accurate and strong verbal and written communication skills with impeccable attention to detail.

+ Synthesizes complex and/or diverse information in order to properly utilize data for decision making and planning.

+ Develops strategies to achieve departmental and organizational goals with support of senior leadership.

+ Effectively and proactively communicates essential information with all levels and business partners.

+ Adept at articulating conclusions from data, raising issues with insight into implications and is persuasive when presenting.

+ Adept at working within approved budget and developing/implementing cost saving measures that contribute to overall company revenue.

**Education and/or Experience**

+ Bachelor of Science in life sciences or similar discipline

+ A minimum of five years combined experience managing or leading Quality Assurance processes and teams

+ Direct experience with medical devices and regulatory environments (i.e. FDA QSR, ISO 9001, ISO 13485, etc.) required

+ Experience and successful track record with regulatory inspections

+ Significant experience in process improvement, manufacturing methods, and procedures and results reporting required

+ Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.

+ Creative in problem solving and solution development.

+ Outstanding interpersonal skills, able to connect and communicate effectively to internal and external customers.

+ Fast learner and adaptable to ongoing changes.

+ Goal-oriented, forward-thinking individual who actively seeks continuous learning and development.

+ Engaged and committed team professional who is eager to contribute to LGC Clinical Diagnostics BU mission and purpose.

+ Passion for continuous improvement and demonstrated initiative towards these goals.

+ Fosters a culture of innovation by always being open to new ideas, encouraging employees to experiment and consider seemingly unconventional ideas, supporting others who take calculated risks, recognizing, and rewarding innovation.

+ Flexibleable to work effectively in a variety of environments and situations

**Physical Demands**

_The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions._

+ Requires prolonged sitting and working at a computer monitor. Repetitive motion using a keyboard for long periods of time. May occasionally be required to lift and move material weighing up to 10 lbs.

**Work Environment**

_The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions._

+ Agreeable work environment typical of an open office setting with some exposure to noise from office machines.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-10-16 Expires: 2020-11-16

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Senior Manager of Quality Assurance - IVD

Kelly Services
Gaithersburg, MD 20898

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