Head of Quality - Parenteral Products & Services North America

Company: Evonik
Location: Birmingham
Posted on: February 24, 2021

Job Description:

This position is responsible for overseeing the implementation and execution of quality systems at the Evonik Health Care sites Birmingham Laboratories and Vancouver Laboratories. Both sites perform manufacturing and service activities in the Pharma Regulatory space of Parenteral and Sterile Finished Dosage forms going into clinical trials or into commercial finished Drug Products. As this is a unique setting for the Health Care business line, the Quality systems of both share similar external requirements (like application of GMP guidelines for sterile injectable dosage forms from the US and EU) and are Centers of Competence. A common approach of Quality oversight and harmonization of Quality systems between the two sites is therefore advised and is an essential purpose of this position.
This position will be key in change leadership with respect to the transformation of Birmingham Laboratories into a growing, Best in Class CDMO. The position is a member of the Site Leadership team responsible for transforming the business model and the site culture while maintaining a high level of GMP compliance through the site's transformation.
This position is responsible for all Quality decisions at the Birmingham site, including final release for all GMP finished products. These decisions have, according to the applicable cGMP rules, to be taken in full independence from head of production or site head. This position is also responsible for ensuring compliance across a diverse range of regulatory requirements including: finished drug product, sterile products, excipients, active pharmaceutical ingredients, medical devices, and bio materials. This includes assuring that quality system procedures and practices meet customer, regulatory, and business requirements. In particular, this position is responsible for ensuring compliance of the site with current Good Manufacturing Practice (cGMP) for finished dosage forms (FDFs), as required i.e. by external laws and regulations such as US 21 CFR part 211 and EU GMP guide Part I.
This position directs personnel and activities of the Quality Assurance, Analytical Quality Control, and Microbiology Labs at Birmingham, which includes overseeing the budget, hiring of personnel, and monitoring of personal performance in these areas. Hosting audits and inspections by customers as well as competent regulatory authorities (i.e. EMA or US-FDA) falls also into responsibility of this position.
This position coordinates Regulatory Affairs activities between clients of Birmingham and Vancouver and RA groups of the Business Line HN-HC. The position is responsible for the upkeep of all DMF's, VMFs and MAFs for Birmingham Labs as well as for the Birmingham Site Master File (SMF) in accordance with applicable regulations.

RESPONSIBILITIES

• People/Organizational Management
• Ensure Performance Planning (PM) and development plans are in place for all staff, and hold reports accountable for successful completion of predefined goals and objectives.
• Responsible for performance management of direct reports. Provide coaching and feedback to assist in the development of direct reports.
• Provide suitably qualified resources of appropriate education, experience and training to execute the roles and responsibilities of the Quality Assurance, Quality Control, and Microbiology Departments.
• Actively coach and mentor staff, peers, and others for the development of future leaders.
• Actively involved in succession planning strategy discussions and represent appropriate employees within area.
• Ensure proper resource utilization and align staffing to effectively support all areas with respect to Evonik requirements and customer expectations.
• Utilize reward and disciplinary processes as appropriate to motivate employees.
• Supervise Quality Assurance (QA), Quality Control (QC) and RA personnel, where applicable through managers of these groups to execute the following:
• Final QA disposition of raw materials and manufactured batches.
• Issue batch rejections or product recall for any instance where product may pose a risk to patient health.
• Manage the QA review and approval of all cGMP activities which includes:
• Investigation of non-conforming product
• Investigation of out of specification (OOS) results
• Change control processes for product, facilities, equipment, systems and procedures
• Corrective Action/Preventive Action (CAPA) program
• Deviation System
• Facility and equipment qualification protocols and final reports
• Process validation protocols and final reports
• Cleaning validation protocols and final reports
• Analytical test method development and validation
• Product standards and specifications
• QA resources for product development teams
• Perform internal audits and self-inspections
• Qualification of materials and suppliers
• Ensure appropriate functional leadership and support for internal and external teams (e.g., Corp, Region, etc.).
• Drive and empower decision making to the lowest level within the organization.
• Strategy/Business Objectives
• Establish departmental goals and effectively communicate direction, objectives, and results as needed to the department, plant site, and Evonik.
• Develop and actively manage team conformance to departmental budget, and drive improved efficiencies in departmental operations.
• Develop, implement and continuously improve the quality system procedures that are effective and compliant to applicable standards, as outlined in ISO 9001, RC 14001, ISO 13485, the IPEC GMP Guide, and applicable cGMP regulations for finished dosage forms (21 CFR 211, EU GMP Guide Part I, etc.).
• Establish cGMP training systems and perform on-site staff training in quality related matters.
• Operate as an independent subject matter expert for the Quality function reporting to Business Line GMP Quality Unit maintaining a business partnership with site manufacturing to ensure delivery of product that meets regulatory and customer requirements.
• Ensure Birmingham Laboratories & Vancouver Laboratories meets business and customer requirements with respect to the development and transfer of testing methods for raw materials, in-process controls, and intermediate and final products.
• Complete new client questionnaires as required by the sales teams to support the development of new customer projects and products
• Author Quality Agreements between Birmingham Laboratories and clients in accordance with BL HC rules and guidance.
• Coordinate and host customer audits and develop audit responses as required by the respective auditing customer.
• Coordinate and host regulatory agency audits, coordinate follow-up communication and supervise necessary corrective actions on site.
• Coordinate and host ISO 9001, ISO 13485, RC 14001 audits.
• Effectively communicate with client Quality / Regulatory personnel to ensure the support of customer requirement.
• Ensure compliance with all commitments (to customers or authorities) in conjunction with regulatory approvals of products and processes originated at Birmingham Labs.
• Manage notification to management and escalate quality issues to Business Line Quality management and customer Quality Organizations.
• Establish and manage QA tracking and trending of essential performance measures and the preparation of periodic reports for management review. Chair the Management Review meetings.
• Propose and develop continuous quality initiatives to improve efficiency, reduce or contain costs, or improve the level of control and compliance. Set up and maintain appropriate KPIs to monitor performance and improvement.
• Provide BL management with monthly reports on site quality performance and regulatory compliance.
• Provide information and updates as necessary for Regulatory Affairs to maintain necessary regulatory filings as appropriate (e.g. Drug Master Files).
• Prepare and submit, upon request from clients, Letters of Authorization, (LOA) for DMF, VMF, MAF.
• Prepare and maintain the Site Master File (SMF) as required by EU GMP regulations.
• Partner with site leadership to implement a shared vision and align strategically with the direction and customer requirements (BMA, DDE, MDCC).
• Primarily responsible for leading the organization through business planning (expense, capital, headcount, and projects) and aligning with various sites and corporate business plans to ensure that the business goals are achieved.
• Understand the Segment, Business Line, Birmingham, and Vancouver priorities to manage the business of the sites and provide strategic guidance to drive site revenue optimization and site expense control.
• Promote a Quality culture at Birmingham Labs with appropriate responsibility and accountability at all levels and functions of the site.
• Participate as a member of Birmingham Labs Site Lead Team.REQUIREMENTS
  • Minimum of a BS Degree in a Scientific field (Chemistry or Engineering preferred)
  • 10+ years of experience in GMP manufacturing, Quality Assurance/Quality Control or similar operational areas in pharmaceutical or medical device industry, thereof at least 5 years in a leading position
  • Knowledge of cGMP requirements and experience in the application and interpretation of cGMP requirements for excipients, finished dosage forms, and medical devices.
  • Strong Leadership skills and experience
  • Ability to travel
  • Knowledge of available software systems including Word, Excel and TrackWise.
  • Strong communication skills (verbal and written)..... click apply for full job details

Keywords: Evonik, Birmingham , Head of Quality - Parenteral Products & Services North America, Other , Birmingham, Alabama