Senior Quality Assurance Specialist

For more than 40 years, our Customer has been following science and seeking solutions to unmet medical needs. They are a biotechnology corporation that makes medicines to treat patients with serious medical conditions. Their goal is to use the power of genetic engineering and advanced technologies to make medicines that address unmet medical needs, and help millions of people worldwide.

We are seeking a Senior Quality Partner on a contract basis to help support our Customer's business needs. This role is onsite in Branchburg, NJ.

This role is accountable for ensuring your contributions are delivered in a way that lives up to commitments to each other. You are responsible for building and developing your capabilities to contribute more to the team, customers and patients. You apply new approaches to improving your work to increase productivity, reduce costs or mitigate significant compliance issues within your area of influence. You work as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.

Responsibilities:

• Drive business results and customer value
• a. Responsible for performing activities as required to meet Q&R goals and objectives independently. Able to identify improvements and implement with collaboration from your manager.
• b. Be recognized internally as an expert in your own job discipline with in-depth knowledge/skill-set of related disciplines in the field.
• c. Act as a coach for colleagues with less experience and help them develop skills/expertise.
• d. Document authoring and review as required to support changes. Performs technical reviews, as applicable. May require collaboration with supervisor on technically complex technical reviews independently.
• e. Preparing documentation for and participating in audits as applicable.
• f. Completing all required training in learning solution.
• g. Responsible for training, coaching and mentoring other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met.
• h. Able to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance.
• i. Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.

• Advance the work of the Network, making tradeoffs and breaking silos
• a. Ability to work day to day with minimal to no supervision to correctly complete daily scheduled and unscheduled activities. Initiates activities independently and initiates interactions across departments as applicable. Initiates daily activities independently. Has courage to make decisions even outside of scope/comfort zone. Is decisive and does not procrastinate on decisions; develop solutions and present both issues and solutions to your manager.
• b. Identify, Initiate, facilitate, participate and implement process improvements to meet business needs. Able to link responsibilities with both site and Global Quality and Regulatory. Drive innovation across the local organization/site.
• c. Leads or contributes with skills to projects/squads within.
• d. Participates in large/global cross-functional or cross-chapter projects.
• e. Be involved in solving unique or unprecedented problems that have an impact on a part of the organization, function or chapter.

• Empower and enable the Network
• a. Build and maintain strong partnerships with colleagues and business patterns to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
• b. Be the champion and advocate for Engrained Quality at the Site.
• c. Build a culture of continuous improvement.

• Enable the organization’s New Ways of Working
• a. Act as role-model for Agile Leadership behaviors, as well as for the culture, mindset & behaviors as defined in the Dia Operating Principles
• b. Model behaviors to support the organization’s transformation to new, more Agile Ways of Working – e.g. new decision making/governance practices, collaboration, etc.
• c. Everything you do should contribute directly to the achievement of the ambitions, including:
• ? Double patient access to novel, high-medical-value diagnostics solutions
• ? Build the leading, profitable insights business
• ? Improve patients’ lives to ecosystem in every country

Skills and Qualifications:

• Bachelor’s/Master's degree in Life Science, Data Science or related subject or equivalent experience.
• 3-5 years experience.
• Completed training as a technician or laboratory technician; or equivalent qualification for the tasks; limited working experience.
• Has worked in more than one function within quality management and may have worked outside of Quality Management.
• Can manage highly complex and/or global projects, or equivalent experience.
• Adopts and adheres to the Leadership Commitments.
• Accountable for meeting commitments.
• Is flexible and able to shift priorities while balancing commitments and daily work requirements, independently.
• Seeks candid feedback on his or her performance and acts on it.
• Recognizes the contributions of teammates and peers.
• Establishes strong collaborative relationships inter-departmentally and across the sites and leverages these connections to achieve our key results.
• Identifies personal goals and actively manages her or his career to pursue personal goals and priorities independently.

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements)

Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.