Quality Lead

Company: Disability Solutions
Location: Philadelphia
Posted on: April 3, 2025

Job Description:

Site Name: USA - Pennsylvania - PhiladelphiaPosted Date: Mar 31 2025As a Quality Product Lead US Fill/Finish, you will provide operational quality (OQ) oversight of combination product device assembly including pre-filled syringes/autoinjectors, and packaging, including but not limited to:

• Product enabling e.g., technology transfer, PQ readiness, Quality Agreements, audit, PQ, registration
• Routine operations e.g., presence and Quality direction (e.g., real time problem solving, support, influence, decision making), deviation, investigation and incident management, review and approval of methods and protocols, periodic product reviews
• Audit/inspection e.g., inspection preparation / management / response, on-going inspection readiness, time cycle audit supportThis role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
  • Recommend and support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met. Build & maintain trusting relationships with external partners whereby influence can be applied & accepted to ensure GSK quality standards are met.
  • Support collection, monitoring and analysis of quality performance indicators of the External Suppliers using quality standards and tools in place to identify/escalate emerging/developing trends. Report and drive resolution of cGMP/Regulatory compliance issues. Request required legal documentation such as Certificate of Pharmaceutical Products (CPP), GMP certificate, Legalized and Notarized Declarations and documents as required by LOCs.
  • Partners with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as testing outcomes, certificate of analysis, batch records, deviations investigations, change controls, validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality.
  • Ensure quality and regulatory compliance for new product introductions and transfers by establishing liaisons and performing actions with GSK Regulatory groups and external suppliers to register and maintain product dossiers. Support compliance with QMS and cGMP requirements of external supplier via GMP Audit process.
  • Support creation and maintenance of Quality Agreement Part A and Bs and IQAs. Support Product Incident Alerts, Stock Recoveries and Product Recalls as directed.
  • Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching and identification of specific inspectional risks.
  • Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
  • Seek clarification on Roles and Responsibilities to ensure team alignment. Complete role-based training as assigned. Communicate on an ongoing basis with the Quality Managers/Director to ensure that potential quality issues are identified and that the support is provided to resolve with appropriate sense of urgency.
  • Conduct OQ duties in accordance with GSK and industry standards, CAPA / deviation / change control / document management, Quality Agreement maintenance, KPI reporting, internal and management monitoring audits, observe operations at contractors (on site and remotely).
  • Maintain strong and credible relationship across GSK and CMO functions to ensure effective OQ oversight while safeguarding the quality / compliance of GSK's products. Support and deliver GSK performance and quality standards to ensure business / supply continuity without compromising quality or compliance e.g., right first time, adherence to schedule.
  • Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
    • Degree in Science or Engineering discipline and 5+ years' experience (Manufacturing, QC, Engineering, Validation or Quality Operations) OR Masters and 3+ years' experience AND/OR equivalency in education and experience.
    • 5+ years' experience in various Technical, Regulatory or Quality Assurance roles with 2+ years of combination product and device and packaging experience.
    • knowledge of GMP's, FDA, EU, ISO13485 and other regulatory agency requirements with an ability to apply to quality and compliance.
    • knowledge of combination product and device regulations
    • knowledge of quality system principles and practical applicationsPreferred Qualifications:If you have the following characteristics, it would be a plus:
      • Developing understanding of quality systems and quality control processes.
      • Breadth of knowledge and experience applying cGMPs, country/region-specific regulations/guidance's with an ability to interpret.
      • Demonstrated sound decision-making process; based on facts & data.
      • Demonstrated ability to work and collaborate in cross-functional teams.
      • Good verbal, written communication and presentation skills.
      • Demonstrated ability to effectively multi-task.
      • Developing Project Management skills.
      • Developing understanding of quality systems principles and practical application.
      • Developing Root cause analysis experience.
      • Capable of working independently.
      • Demonstrated continuous improvement behaviors including problem solving.
      • Previous exposure within a contract manufacturing environment.
      • Good interpersonal and negotiation skills; with demonstrated ability to influence stakeholders.
      • Demonstrated flexibility, ability to adapt and accommodate different/ multiple work demands.
      • Developing understanding of current FDA/EMA/ISO validation practices including device assembly, packaging, performance process qualification, shipping, computer systems, functional test methods.
      • ISO 13485 auditor certification
      • Demonstrated problem solving skills.
      • Demonstrated ability to make grade level decisions based on facts and data and application of risk management principles.
      • Experience with work related travel
      • Excellent written and oral communication skills -English; Developing presentation skills#LI-GSK#Globalsupplychain#FeaturedmanufacturingjobsThe annual base salary for new hires in this position ranges from $87,750 to $146,250 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 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/ AgenciesGSK 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 at https://openpaymentsdata.cms.gov/

Keywords: Disability Solutions, Philadelphia , Quality Lead, Other , Philadelphia, Pennsylvania