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Title: Senior Manager of Quality Assurance
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Senior Manager of Quality Assurance
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 team’s workflow as needed to meet internal and external customer needs and regulatory requirements.
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: 125-130K
- Job Location: Gaithersburg, MD
- Job#: bh11649
- Date Posted: 8/31/2020
- 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.
- Flexible—able to work effectively in a variety of environments and situations
Please use the apply button to submit your resume for consideration. A Connexon Representative will contact you immediately.
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