Quality Compliance Manager

GlaxoSmithKline

285d

About The Position

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.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree