Sr Mgr Quality - Validation

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

SCOPE OF POSITION:

The Sr. Manager of Quality Validation will oversee qualification and validation activities for equipment, utilities, software, and manufacturing processes across the Specialty Generics business unit. Activities support continuous operations, new product development, and process improvements. The Sr. Manager will also be responsible for the data integrity program, including management of assessments and implementation of associated mitigations for both laboratories and manufacturing.

ESSENTIAL FUNCTIONS:

• Provide strategic and technical input into standard and best practices for qualification and validation in order to maintain and advance the state of the art in validation technology --- included in this function is the use of validation technology and principles to improve quality while reducing the overall cost and risk of business
• Ensure that the software quality function meets all pertinent regulations and guidance documents
• Develop and provide proper training to maintain knowledgeable professional staff
• Ensure that equipment, ancillary systems, and processes meet all pertinent regulations and guidance documents
• Provide interpretation and guidance of (current Good Manufacturing Practices) cGMP and other regulatory documents with regard to validation and compliance
• Provide support and guidance to the Quality organization and site leadership regarding enhancement of cGMP compliance and quality performance improvements
• Provide on-site direction and consultation on the various aspects of validation
• Ensure consistency of validation processes
• Review and approve site validation policies and ensure their implementation
• Participate in compliance audits and respond to audit observations
• Provide resources to other functional groups for information and decisions relating to process, cleaning validations, water and utility issues
• Stay abreast with cGMP and validation requirements by attending conferences, seminars, and training courses
• Participate in site Environmental Health and Safety, Operational Excellence, Lean, Quality Improvement Plans, and related initiatives designed to improve site operations to meet key business objectives

MINIMUM REQUIREMENTS:

Education:

Bachelor's degree in chemistry, microbiology, related life sciences or equivalent combination of education, experience, and competencies.

Experience:

Minimum of 15 years of pharmaceutical industry experience in Validation including experience in manufacturing and control of solid dosage form drug products and bulk drug substances. Minium 5 years managerial experience in a pharmaceutical environment with proven personnel and project management history. Complete knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11 and Data Integrity requirements. Knowledge of ICH Q7 and Q11 required.

Preferred Skills/Qualifications:

It is preferred that the candidate will also possess several of the following:

Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations. Exceptional oral and written communication skills. Strong managerial and excellent negotiating skills in order to obtain balanced results from direct and indirect reports. Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host. Strong customer focus. Ability to lead and influence people.

Skills/Competencies:

Desired skills and competencies include:

Writing skills necessary to effectively communicate technical/clinical information to others. Comfortable and capable of using software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies. Superior verbal communication skills including impeccable etiquette. Scientific literature evaluation skills. Scientific literature searching skills.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

• Reports to Sr. Director, Quality and Regulatory Affairs
• Manages a group of approximately 7 high level professionals supporting the SpecGx Validation Center of Excellence
• Generally accomplishes results through individual level contributors
• Works closely with the key Sector and site executives on issues of major importance to the business
• Frequent contacts with external customers, regulatory agencies, and individuals from across the company

WORKING CONDITIONS:

• Normal office conditions
• Approximately 20% travel (most site locations are based within an hour of downtown St. Louis) will be required for manufacturing site visits and off-site business meetings

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.