Head of Quality - Parenteral Products & Services North America
Posted on: February 24, 2021
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
- 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
- Provide suitably qualified resources of appropriate education,
experience and training to execute the roles and responsibilities
of the Quality Assurance, Quality Control, and Microbiology
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Participate as a member of Birmingham Labs Site Lead
- Minimum of a BS Degree in a Scientific field (Chemistry or
- 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
- Strong communication skills (verbal and written)..... click
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Keywords: Evonik, Birmingham , Head of Quality - Parenteral Products & Services North America, Other , Birmingham, Alabama
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