Dive headfirst into a highly technical quality assurance role that allows you to catalyze compliance and mitigate risk, all from within a state-of-the-art manufacturing environment. As a Quality Compliance Manager, you will be responsible for the implementation and sustainment of an industry-standard quality inspection readiness plan; you'll also coordinate and participate in internal and external audit programs, including regulatory inspection readiness and regulatory commitment management; additionally, you will be responsible for oversight of product surveillance. These main duties come with a few, more detailed responsibilities.
- Hire, lead, develop and support Quality professionals at the Lincoln Site to ensure the necessary programs are in place & comply with regulatory agencies' and company requirements.
- Work directly with Site Leadership Team daily to complete all pertinent inspection readiness activities.
- Host internal customer audits, write & coordinate the issuance of a timely response for any observations (including follow-up reports), and manage internal commitments to ensure timely follow-up and completion as committed to the audit functions.
- Maintain the site's internal audit and self-inspection programs, as well as ensure that rigid product surveillance processes are in place to ensure identification of necessary actions throughout product life cycle.
- Act as a coach or mentor using appraisals, 1:1's, training and development, performance management, talent management and reward and recognition.
- Approve GMP related documentation such as SOPs, CCRs, Deviation, Validation/Qualification documents and Technical Reports. Approves any changes associated with these documents.
The following experience is required for the role:
- Bachelor's degree in Science, Engineering, or similar
- 7+ years of experience in the Pharmaceutical Industry in Quality Assurance or Compliance
Individuals possessing the following characteristics will take precedence:
- Master's degree in Science, Engineering, or similar
- Knowledge and application of the principles of Quality Management Systems (QMS)
- Knowledge of cGMP's/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11
- Clear sense of ambition and analytical problem solving skills - ability to use and interpret data to drive decision-making at both the tactical and strategic levels
- Project management and leadership skills
- Ability to work well under high pressure and deadlines
- Flexible, adaptable, and a leader who fosters teamwork
- Excellent verbal and written communication skills
- Conflict resolution and interaction management skills
- Even-keeled decision-making - using evidence and applying judgment to balance pace, rigor, and risk.
- Committed to high quality results, tenacity, and laser focus.
- Dedicated to stability and well-being, building resilience across the institution.
- Continuous opportunities to learn, build skills and share knowledge both internally and externally.
- Developing people and building a strong talent pipeline.
- Building strong relationships through collaboration and managing trusted stakeholder relationships internally and externally.
- Financial and social foresight, and according adjustment.