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Site Quality Director

3 weeks ago

Rockville, Maryland, United States GSK Full time

Site Name:
USA - Maryland - Rockville

Posted Date:
Sep

Are you looking for an opportunity to lead and inspire Site Quality teams toward the pursuit of operational excellence in manufacturing practices while building a high-performance network? If so, this is the role for you.

As
Site Quality Lead Director
, you will provide strategic leadership and direction for the site's Quality function, ensuring the highest standards of product quality and compliance with GSK corporate policies and regulatory standards. The role is accountable for the quality of all products released from the site and for representing GSK in health authority interactions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following
:

  • Strategy Deployment: Serve as a member of the site leadership team, actively contributing to strategy deployment to support GSK objectives.
  • Quality and Compliance Strategies: Develop and implement quality and compliance strategies and initiatives, ensuring full deployment of GSK's Quality Management System (QMS).
  • Continuous Improvement Culture: Foster a culture of continuous improvement, developing and monitoring key quality metrics to drive performance.
  • Quality Leadership: Provide leadership and direction in all Quality related matters, ensuring operational business compliance with cGMP and regulatory requirements.
  • Team Development: Lead and develop the Quality organization on site, making decisions that prioritize patient safety and product quality.
  • Strategic Quality Planning: Develop and execute a long-term quality strategy that aligns with the overall business objectives, ensuring that quality considerations are integrated into the site's strategic planning and decision-making processes.
  • Regulatory Compliance: Maintain a state of inspection readiness by staying abreast of regulatory changes and trends, and ensuring that the site's quality systems and processes are robust and compliant with current industry standards and practices.
  • Quality Culture and Employee Development: Champion a strong quality culture throughout the site by promoting quality awareness, accountability, and continuous improvement. Develop and mentor quality personnel to build a pipeline of talented quality professionals capable of supporting the site's current and future needs.

Leadership Competencies:

  • Patient Focus: Lead with a patient-centric approach in all quality-related decisions and actions.
  • Integrity: Uphold the highest ethical standards, ensuring transparency and honesty in all operations.
  • Respect for People: Foster an inclusive environment that values diversity and encourages collaboration and innovation.
  • Do the right thing: Demonstrate the courage to make tough decisions and challenge the status quo in the best interest of patients and the company.

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

  • Bachelor's Degree with 10 plus years of experience in pharmaceutical OR biological production environments
  • Experience with FDA/EU/ICH/CDN/AUS guidelines
  • Leading First & Second Line Managers
  • Experience working with Site Leadership Team
  • Experience with patient safety and product quality

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

  • Experience in leading cross-functional teams and driving organizational change
  • Excellent interpersonal and communication skills, with the ability to engage effectively with stakeholders at all levels
  • Strong knowledge of good manufacturing practices and data integrity
  • Demonstrated ability to challenge the status quo and drive continuous improvement
  • Ability to make risk-based and autonomous decisions

This position is located onsite in Rockville, MD.

The annual base salary for new hires in this position ranges from $201,300 to $335,500 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

**Why GSK?

Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website