Operational Quality Manager
Marietta, PA 
Share
Posted 9 days ago
Job Description
Site Name: USA - Pennsylvania - Marietta
Posted Date: Apr 19 2024

Are you a Quality Manager looking for a challenging opportunity to drive Quality Operations improvement and simplification for your local region while working with Quality Managers across the globe? If so, this could be a great position to explore.

As an Operational Quality Manager, you will be responsible for Quality Assurance oversight of Operations in your local region to meet both regulatory and customer expectations. This includes harmonizing the quality standards and simplifying processes while driving both compliance and efficiency.

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

  • Accountable for the evaluation of manufacturing operational practices to ensure compliance with regulatory requirements.
  • Lead, develop, implement and influence changes to meet requirements.
  • Ensure all validation, quality, safety and environmental procedures and regulations are met, maintained and documented appropriately.
  • Accountable for leading and developing the QA Operations Team.
  • Accountable for review and approval of all cCMP documentation generated by all overseen functions.
  • Accountable for the accuracy and completeness of all master batch records and all production batch records.
  • Accountable for quality unit business processes and ensuring that they are standardly and correctly used by all overseen functions.
  • Accountable for frequently and routinely measuring and communicating the performance and effectiveness of QA Operations.
  • Represent the site directly with domestic and foreign regulatory inspectors regarding Operation Quality.
  • Schedule Operational Quality support, as required, to support 3 shifts of operation.
  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

Why you?Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor of Science
  • Minimum of 7 years industrial experience in pharmaceutical or vaccine manufacturing; either in operations or quality assurance functions.
  • 5 years prior experience managing quality assurance (Quality Systems, compliance, product release) within clinical or commercial organization OR 5 years prior experience supervising biologics manufacturing to include delegating, training, communicating and prioritizing site objectives, evaluating, coaching and discipling others.
  • 5 years of Prior experience with licensed biopharmaceutical or biological products.

Preferred Qualifications:

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

  • Must be able to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
  • Champion change and innovation, drive execution and results, motivate others and foster collaboration at all levels of the site.
  • The ability to drive site objectives and results; work in a fluid environment; drive culture & lead department initiatives.
  • Demonstrated interpersonal and leadership skills.
  • The ability to function and influence within team-based organization.
Why GSK?

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Get Ahead Together.

#LI-GSK

#GSKMarietta

#MariettaGSC

Please visit 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 special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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 GSK's Transparency Reporting site.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
7+ years
Email this Job to Yourself or a Friend
Indicates required fields