Title:  GM Global Quality - CPV / Statistical Product Analysis

POSITION SUMMARY

Direct the Global Quality Continued Process Verification (CPV) program and Statistical Product Assessments, ensuring a smooth transition from Stage 2- Process Performance Qualification (PPQ) and Stage 3 – Continued Process Verification (CPV), in order to enhance drug product lifecycle management. Create a Community of Practice for the use of all statistical tools in drug substance / drug product assessments (Process Performance and Capability Analysis, Linear regression product shelf life studies, Before/After hypothesis testing, ANSI/ASTM Sampling tables, statistical trending of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Critical Material Attributes (CMAs), etc.)

The incumbent will participate directly in specialized training development in conjunction with the roll-out of enhanced Global Quality Standards for Validation Activities (Stage 2 / Stage 3), and the creation of a new Global Quality Standard for Statistical Product Analysis (SPA) utilizing Minitab® statistical software.

Key responsibilities:

1.  Co-author Global Quality Standard for Stage 2 – PPQ & Stage 3 – CPV Validation activities.
2.  Collaborate with the electronic Annual Product Quality Report (APQR) project teams to standardize a CPV business report and user workflows within the software development process.
3.  Co-author Global Quality Standard for Statistical Product Assessments (SPA).
4.  Training development, delivery, project management and Global roll-out schedule for all new Quality specialized training programs for both CPV & SPA.
5.  Author, communicate and deliver to all levels of the organization from executive presentations to factory/lab areas, on all CPV & SPA specialized training and qualification programs.
6.  Liaison with Sun Pharma sites on statistical trending within the CPV program to identify statistical Out of Trend (OOT) conditions, and assist in site CPV meetings and Quality Investigations as the Global Quality Subject matter expert for CPV and SPA.
7.  Co-manage the business relationship and the Sun Pharma contract with Minitab® Statistical software in conjunction with the Quality IT department.
8.  Project manage the Computer System Validation of Minitab® statistical software for its intended use with APQR/CPV reporting.

MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS

Health Science, Pharmacy or Industrial Engineer Graduate or Equivalent

20 + years Pharmacy industry experience

REQUIRED SUCCESS ATTRIBUTE (prioritized)

1. Drug Substance and Drug Product Validation and lifecycle management (Stage 2 / Stage 3)
2. CPV and SPA Technical report writing
3. Training Development
4. Training Delivery (class room & virtual)
5. Project / Team management
6. Knowledge of GxP’s, cGMP and other regulatory requirements.
7. ICH, and health authority regulations governing Quality investigations, CAPA, APQR & CPV
8. Time management
9. Site service orientation

Secondary Success Attributes

• Information Technology Learning Management Systems (LMS)
• People Connect
• Attention to detail
• Business traveler (25-50%)
• Effective Communication from operator to executive levels

Roles

Additional responsibilities can be assigned as required.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

Incumbent performs work assignments in both normal office and both aseptic / non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.

DELEGATION OF RESPONSIBILITY

In the absence of job holder, delegation of responsibility will be as follows:

Upward Delegation – Strategic corporate responsibilities to higher level

Downward Delegation – Site Operational responsibilities to indirect project reports or similar peer job roles