Title: Quality Assurance Sr Manager Assoc Director at St-Renatus in Fort Collins CO
Company: St. Renatus
Location: 1000 Centre Ave, Fort Collins, CO
Job Type: Full Time
- This position will provide Quality leadership and oversight of contract manufacturing organizations (CMO) plant operations.
- Ensuring appropriate application and execution of cGMP compliance requirements for combination product.
- It will also review and revise current quality policies in place and further develop and execute St. Renatus’ Quality Management Systems in a manner that ensures successful deliver of cGMP Quality Assurance.
- This position performs related tasks that fall under the broad category of Quality Assurance functions.
- Such tasks will include conducting investigations, determining and/or completing corrective and preventive actions (CAPAs),
- Reviewing Master Batch Records and Master Packaging Records,
- Reviewing Validation Protocols and Qualifications, conducting audits,
- Evaluating change controls for impact on other cGMP systems.
- In addition, this position will manage all aspects of the document control and training program and be responsible for authoring standard operating procedures.
- Maintain the cGMP Quality Management System and standards for all aspects of supply chain.
- Provide virtual cGMP Quality oversight for all manufacturing, packaging, storage, and distribution activities to ensure compliance.
- Perform final batch release activities for products manufactured by third parties.
- Review all third parties contracted to perform any functions in support of the cGMP manufacture of clinical supplies and commercial product.
- Identify cGMP compliance gaps or risks.
- Identify and monitor vendor performance metrics and improvement targets.
- Prepare, review, and monitor vendor adherence to Quality Agreements.
- Plan and conduct cGMP audits of manufacturing activities to assess compliance with pertinent regulations, as well as, with company SOPs.
- Review and approve product specifications, stability protocols/data, manufacturing deviations, Corrective Action Preventative Actions (CAPAs), SOPs, Change Control procedures.
- Establish the processes and communications to enable effective delivery on cGMP Quality commitments to build a culture of quality and continuous improvement.
- Ensure prompt communication of cGMP compliance risks to senior management.
- Oversight of pharmacovigilance monitoring program.
- Maintain Quality documentation files.
- Coordinate CMC compliance with Regulatory Affairs, including technical writing and review.
- Execute improvement activities, prepare periodic quality reports, and communicate progress to stakeholders.
- Oversee and facilitate Product Recall System.
- Ensure the periodic assessment of compliance standards and communication of compliance liabilities to senior management. Communicates this assessment on a regular basis.
- Develop and deliver cGMP compliance training and participate with training and development of staff.
- Participate as member of the management team in planning to achieve site goals and objectives; communicates and helps resolve issues or problems that have interdepartmental impacts and in planning to enhance and expand the opportunities
- Determine necessary headcount within Quality area to ensure delivery against goals.
- Management responsibility for non-exempt, exempt and/or supervisory level personnel as the company grows.
- Travel for this position is required (Approx. 10-15% Domestic)
Education / Experience
- BS or BA degree preferred, with emphasis in biosciences, biomedical, or medicine.
- Strong scientific background with at least 8 years of relevant experience in Quality Assurance in the manufacturing environment within the pharmaceutical industry.
- Thorough knowledge of quality systems, compliance regulations, scientific terminology, quality assurance procedures and policies, the use of computer and software developmental methodologies and quality auditing/evaluation techniques.
- Must have experience in the use of controlled documents and related quality systems.
- Previous experience with pharmaceutical production processes and Quality Control analytical methodologies.
- Knowledge of the principles of Quality Management and Continuous Improvement.
- Proven track record of successfully managing Quality Management, Quality Assurance, and Quality Control throughout the lifecycle of a pharmaceutical product.
- Experience in pharmaceutical equipment operation, design and control.
- Experience in leadership roles
- Facility Licensing, Regulatory audits and inspections for combination products.
- An investigational nature is essential in evaluating Quality problems.
- Maintains thorough and ongoing knowledge of cGMP methods, compliance and regulatory standards.
- Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.
- Outstanding verbal, written and interpersonal communication skills. Effective written and oral communication skills is required.
- Demonstrated attention to detail with solid coordinating, task planning and time management skills.
- Must be multi-task oriented and organized to work within numerous systems and programs.
- Demonstrated skills in strategic thinking, problem solving, advising, risk assessment, risk mitigation, decision making, and implemention.
- Strong computer skills including but not limited to Microsoft Office products such as Outlook, Word, Excel, and PowerPoint, and ERP software related to manufacturing and project management.
- Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
- Demonstrated ability to build confidence among contract manufacturers, vendors, peers, customers, and others, quickly.
- A positive, winning attitude.
To apply, please send resumes/cover letters to: Recruiting@st-renatus.com