Quality Compliance Manager

Are you energized by a role that provides leadership for the quality assurance staff ensuring that quality objectives are met and site operations are in compliance with all applicable quality policies and procedures? If so, this Quality Compliance Manager could be a great opportunity to explore.

At GSK, we are hiring a Quality Compliance Manager who will be responsible for developing, planning, and executing QA compliance programs at Upper Merion Biopharm to meet applicable regulatory requirements and corporate quality goals. This position requires an extensive working knowledge and understanding of cGMP regulations and industry trends, especially as they affect the biopharmaceutical industry. This position also requires the ability to handle multiple projects and interface with individuals from various departments (internal and external) and at various levels.

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

• Provides interpretation of regulatory quality and compliance requirements and ensures integration into site quality systems. Oversees site Regulatory Compliance team responsible for assessing regulatory impact and coordinating site efforts and evidence to assure all mandatory licenses and registrations (BLA's/MAA's) are kept current and in compliance with applicable requirements.
• Is accountable for the program for mapping and assessment of quality systems to identify compliance gaps, including management of the internal business monitoring and management monitoring audit programs.
• Is responsible for the internal audit program, and oversees Inspection Readiness preparation and routine activities for GMP surveillance , pre-approval, and other regulatory inspections.
• Oversees management of document control and the routine development, updates, reviews, and approvals of cGMP documents to conform to QMS and health authority regulations.
• Oversees the site Change Control system responsible for documenting and assessing impact of proposed technical changes. Reviews and approves local changes and provides necessary impact assessments.
• Oversees management of 3rd Party Suppliers (Vendors) and Service Providers, including their selection, assessment/ audit, approval, control, oversight, and exit. Additionally, oversee programs assessing impacts of changes to supplied materials and services, and where necessary issuing Vendor complaints.
• Accompanies or substitutes for the Site Quality Director and participates in aspects of external regulatory inspections at the site. Directly interface as a host with auditors during inspections. Assists, when required, in the drafting of necessary correspondence with regulatory agencies, related to inspections or other GMP matters. Coordinates site preparation and CAPA planning activities and issues Executive Summaries. Maintains files of documentation associated with past regulatory agency inspections.
• Manages the Customer Complaint Program (including Adverse Findings). Investigates the complaints, schedule testing to address issues, prepare responses and reports to appropriate departments the results.
• Manages compliance activities including compilation of annual report/periodic quality review and Distribution Risk Assessments for all products manufactured at UM Biopharm.
• Leads routine site Tier 1 Quality Council, to review the performance and effectiveness of quality systems, check they are operating as expected and identify risks and improvement opportunities. Ensures regular reporting of quality and performance metrics to affected groups and upper management.

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

• Bachelors degree.
• 7+ years pharmaceutical industry experience in either operations or quality assurance functions.
• 3+ years prior experience leading teams.

Preferred Qualifications:

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

• Bachelor's of Science in Chemical or Biological Sciences is preferred.
• Masters degree in quality or regulatory.
• Bio-pharma experience.
• Bulk drug substance experience.
• Leading people within Quality Assurance.
• Experience in highly regulated and complex environment, ability to effectively manage workload.
• In-depth experience in quality systems, including validation, compliance, and running a high volume, rapid turnaround operation.
• Strong technical understanding of industry and science practices related to the business.
• Prior experience with leading significant improvement programs.
• Fully versed in GMP's, NIH Guidelines, FDA and other regulatory agency compliance requirements for validation and operations, and analytical and stability functions.
• Strong interpersonal and leadership skills. Solid team player able to function within team-based organization.
• Strong verbal and written communication skills.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, supply chain operations, production, QC, finance and EHS.
• Able to prioritise and decide appropriate course of actions. Effective at implementing decisions.
• Excellent organization skills as well as effective verbal/written communication skills.

#LI-GSK

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/ 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 at https://openpaymentsdata.cms.gov/