Description:
- Installs and leads quality organization (QA, QC) at the Walkersville Site
- Assures that the site remains under control with respect to GMP/ISO compliance, collaborating with Operations to solve quality issues.
- Accomplishes corporate business objectives by developing site quality systems and enforcing Regulatory compliance
- Acts as Key Account Quality Manager for selected customers
- Leads & supports Audits & Regulatory Inspections at the Walkersville Site
- Leads and directs staff in both QA and QC
- Develops manufacturing and process controls and improves quality systems
- Member of the Walkersville Site Leadership team
Primary Accountabilities, Duties and Responsibilities
The Head Quality Unit for the Walkersville Site, is the leading source of Quality/Regulatory-related expertise within the Walkersville Site and is responsible for providing the strategic leadership and management for the Site`s Quality organization
Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a world-class team
Develop and execute the Walkersville Quality strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Quality and business strategies.
Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity. Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GxP standards, ISO standards, corporate policies, FDA and other regulatory body regulations and guidelines.
Serve as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction. Oversee all partner and regulatory authority audits and inspections and corrective action programs in response thereto
Evaluate all current Quality systems and processes and recommend and implement appropriate enhancements to ensure the achievement of companies’s long-term objectives
Create active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Walkersville Quality functions.
Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent the companies on quality and cGxP compliance issues that are specific to Walkersville
Serve as the company Quality expert, providing solid, well-informed, actionable Quality support to Walkersville Operations, R&T, and other functions as requested.
Perform other duties as assigned.
Essential Job Functions
Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
Quality Responsibility
Adherence to cGMPs (and/or ISO standards) is required at all times during the manufacture of APIs, Drug products, Media, LAL related and research products. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
Minimum Required Qualifications/Skills
Experience
- 10+ years direct job related experience in GMP facility manufacturing products regulated by CBER, CDER or CDRH with a minimum of 7 years’ experience in Quality Management
Working knowledge of:
- Aseptic practices and clean room operations
- Statistical and auditing techniques
- Environmental control procedures/equipment
- Expert knowledge of GxP, ISO Standards, FDA regulatory requirements applicable to FDA regulated products
- Regulatory Knowledge CBER, CDER, CDRH
- Strong knowledge of current industry trends and has the ability to use the latest technologies.
Skills
Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills
Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues. Routinely report on quality and compliance issues
Qualities & Attitude
Demonstrated leader in the field with sustained performance and accomplishments. Ability and experience in turning around and remediating compliance challenges. Ability to plan and budget at a senior level.
Diplomacy, negotiation skills, written and oral communication, team building skills, independent work skills, strong work ethic, coaching, delegating skills