Qa Manager Jobs

Responsible for reviewing and maintaining cGMP batch documentation, interacting with cross-functional team members and external manufacturing vendors and analytical contract labs and assist in the conduct of external and internal audits or for evaluating and trending data generated from product complaints and other quality systems, compiling reports and reporting findings and recommend solutions for issues to management. Provides QA oversight to ensure compliance with company policies and procedures, ICH, FDA and EU requirements, cGMP, and other applicable requirements

• Other Duties as assigned
• QA Manufacturing
  • Participate on project teams, serving as the QA representative and escalate issues to senior QA management when appropriate
  • Review and assess API, drug and finished product(s) batch records and analytical records for clinical and commercial products in a timely manner
  • Review and assess stability data supporting retest period and assign retest dates for clinical products
  • Review Method Validation reports
  • Manage, process and participate in deviation investigation teams
  • Interface with cross functional groups or CMOs to process batch documentation and resolve issues
  • Facilitate the change control process for changes related to clinical and commercial products
  • Maintain tracking logs for quality systems
  • Prepare reports for management review of key statistics such as vendor performance based on findings from batch and analytical record reviews
• Facilitate the change control process for changes related to clinical and commercial products
• Work closely with QA management to ensure compliance to regulations, guidelines, and GXP SOPs
• Participate on project teams, serving as the QA representative and escalate issues to senior QA management when appropriate
• QA Department Support
  • Assist with identifying, implementing and training all departments that utilize GXP Quality Systems (e.g., QMS, EDMS, LMS) with improvements and applicable regulations and guidelines
  • Work closely with QA management to ensure compliance to regulations, guidelines, and GXP SOPs
  • May work on other projects within QA not related to Quality Systems and other duties as assigned
• Participate in the development, implementation, and administration of an organizational QMS and monitors progress against strategic quality-related goals
• May work on other projects within QA not related to Quality Systems and other duties as assigned
• Review and assess stability data supporting retest period and assign retest dates for clinical products
• Assist with identifying, implementing and training all departments that utilize GXP Quality Systems (e.g., QMS, EDMS, LMS) with improvements and applicable regulations and guidelines
• Maintain tracking logs for quality systems
• Manage, process and participate in deviation investigation teams
• Interface with cross functional groups or CMOs to process batch documentation and resolve issues
• Solicit internal and external feedback with the goal of continuously improving processes or products
• General Quality Assurance
  • Administer policies and programs ensuring that organizational products and processes meet established quality standards
  • Participate in the development, implementation, and administration of an organizational QMS and monitors progress against strategic quality-related goals
  • Solicit internal and external feedback with the goal of continuously improving processes or products
• Review Method Validation reports
• Administer policies and programs ensuring that organizational products and processes meet established quality standards
• Review and assess API, drug and finished product(s) batch records and analytical records for clinical and commercial products in a timely manner
• Prepare reports for management review of key statistics such as vendor performance based on findings from batch and analytical record reviews

• Ability to identify and escalate problems and follow-through with the corrective actions
• Strong communication and proficient soft skills
• Frequently works cross-functionally as the representative for their area
• Knowledge of quality systems and regulatory compliance requirements within pharmaceutical or biotech environment
• Ability to solve problems and work collaboratively in a team environment
• Proven ability to quickly learn new information and communicate requirements to the appropriate individuals
• Identifies and resolves technical, operational and organizational problems/problems relating to own discipline
• Requires understanding of how the team / work area relates to other related areas and uses that knowledge to improve efficiency and produce high-quality work on problems with cross-functional impact
• BS, BA degree in life sciences or related field or RN and 8+ years of in scientific or health care field and pharmaceutical industry experience, including 5+ years of QA experience in drug development. Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines including research of principal investigator regulatory histories. Some managerial / functional management or lead experience preferred
• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors
• Ability to manage teams and personnel and ensure development of programs and individuals in GXP processes
• Attention to detail, critical thinker, and effective organization skills required
• Strong EDMS and computer skills to include Excel, Word, Adobe Acrobat, PowerPoint, Visio, DocuSign, Compliance Wire, Veeva Vault, and Veeva Quality Docs
• Works well in a team environment with the ability to drive results
• Must possess strong verbal and written communication skills along with sound organization skills applicable to audit planning, reporting and archiving
• Master's degree in life sciences or related field and 6+ years of similar experience noted above

The annual base salary we reasonably expect to pay is $107,700.00-$172,300.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.