*** Role is based at my client's Global HQ in the Rocky Mtns - Relo is provided ***
My client is a $2B+ multinational CPG company that is celebrating another record setting year. To help keep up with their incredible and sustained growth they are looking for an outstanding VP Quality to lead their global QA teams (4+ Manufacturing Sites in NA and 3 additional sites in ASIA).
Job Summary: Reporting to the President, the VP of Quality Assurance is responsible for the manufacturing Quality Assurance and Regulatory compliance program for the company. FDA responsibilities include compliance to Drug Laws (21 CFR 210,211), Supplement Laws (21 CFR 111) and Food Laws (FSMA, HACCP). The VP manages all personnel, strategy and all aspects of QA at all manufacturing facilities, including the quality inspections group, laboratory group, validations, document control, supplier quality, internal / external audits, customer complaints, and corrective action.
Key Responsibilities
Responsible for North America quality and quality improvements assuring compliance of all GxP systems for products manufactured and distributed from their manufacturing facilities.
Accountable for the performance of the Quality Assurance and Quality Control departments including compliance, measuring Key Performance Indicators, internal and external customer satisfaction, timely testing and release, labeling, relationships with regulators and customers, talent management, departmental budget and effective communications related to quality initiatives.
Manage North America Company's Quality Management System (QMS) and Documentation Department responsible for the review / approval of a GxP procedures and records retention. This includes the company-wide training, determination of training needs against metrics, and management of employee training records. This also includes supporting computer system validation documentation and business continuity documentation needs.
Assure compliance metrics are appropriate measures of life cycle and new product compliance. Conduct trend analysis of audit/inspection observations and communication of results expediently to applicable groups. Expedite key documentation processes requiring a high level of responsiveness for Exceptions, Out of Specification results, Corrective Actions and Preventative Actions.
Serve as a technical / quality system resource and actively collaborate with Manufacturing / R&D / PMO / Supply Chain / Regulatory Affairs and Medical / Commercial organizational counterparts making quality decisions for new project teams and life cycle product teams. This includes leadership on Quality by Design, Failure Mode Effect Analysis, and Risk-Based Decision Making.
Drive Change Management Process, Materials Management Process and in-coming goods processes and support 21 CFR 210,211, 21 CFR 111, FSMA, HACCP manufacturing
Optimize and manage the internal auditing program and collaborate cross-functionally to ensure compliance; plan and execute compliance audits of internal operations as they relate to GxPs and drive timely completion of associated corrective actions.
Oversee the management of external and Health Authority inspections, ensuring compliance with policies, procedures and regulatory requirements. Act as key liaison for local, state, federal, and global regulatory agency inspections. Proactively seek to affect change to reduce the number of observations identified during audits / inspections and ensure company is aligned with current regulatory expectations.
Oversee and review recommendations and implementation of improvements induced by new regulations, agency guidance documents, industry standards, new technologies and internal needs.
Conduct ongoing surveillance of worldwide regulations and establish procedures and policies to comply with everchanging regulatory environment. Maintain awareness of science and industry trends and integrate appropriately into work focus.
Actively demonstrate the Curium values of Integrity, Commitment and Collaboration as well as Accountability, Efficiency, Customer Service, and Safety.
Other essential job duties are:
Expertise in OTC, supplement and food GMPs requirements
Principle Quality interface with manufacturing operations
Oversee the activities of International market quality complaints and investigations
Principle contact and interface for all FDA audits at all facilities.
Annual Product Review reporting for OTC drug manufacturing
Supports Internal and Supplier Quality audits (travel required)
Supports nationwide and worldwide implementation of QA systems (some travel required).
Performs other duties as assigned or needed (including, but not limited to):
Annual Product Reviews
Investigations
Quality improvements team leader and/or member
Other activities as defined by senior management
To be a good fit for this opportunity you will have:
Ability to relocate
Ability to work onsite and travel internationally
10+ years' Quality Assurance Leadership for large consumer product or food in a regulated industry.
Experience creating a Global QMS
A working knowledge of Federal Regulations regarding the manufacturing and distribution of drug products, nutritional supplements and food safety
Demonstrated knowledge of GLP and GMP.
Demonstrated experience authoring/reviewing validation protocols, standard operating procedures, and technical reports.
Ability to understand schematics/drawings and basic utility and equipment specifications
Ability to multi-task in a fast-paced environment and manage different priorities.
Strong leader with proven track record of managing and developing a large and diverse group of people.
Experience with managing external audits and conducting internal audits.
Excellent computer skills with word processing, spreadsheet, and database.
Excellent technical writer with a high level of attention to detail.
Strong written, verbal, and presentation skills.
Ability to mentor others.
Proficient mathematical and statistical skills especially related to SPC.
Ability to work independently and with other departments.
Ability to organize and coordinate projects and perform multiple tasks in a fast paced setting with efficiency and accuracy.
Ability to prioritize and make decisions based on risk.
Self-starter, task oriented professional.
Bachelor's degree
Just as important as your experience and skills will be the following characteristics and competencies:
Self-motivation and a strong sense of ownership and accountability
The ability to produce consistent quality under deadline pressure while paying careful attention to detail
A collaborative approach and willingness to engage in an environment of active idea sharing
A natural orientation for continuous improvement and problem solving