Quality Compliance Lead

Company Description

We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.

**Job Description**:
**Job purpose**

To execute and track improvements in the quality compliance activities and status required within the site operations to comply with cGMP and customer expectations related to active pharmaceutical ingredient manufacturing, with a major emphasis on real-time inspection readiness and quality metrics reporting.

**Principal accountabilities**:

- Lead the real-time inspection readiness programs at the site through design and execution of efficient, effective internal audits and compliance monitoring programs.
- Lead GMP, and quality risk gap analyses, create and lead action plan teams.
- Perform Quality Risk Management assessments and support other departments during risk analysis assuring the inclusion of patient safety risk and customer concerns.
- Assist in customer complaint investigations and engagement with customer as needed for resolution.
- Assist in creation of GMP training program to include customer and agency inspection feedback
- Create fit-for -purpose implementation plans to address revisions in GMP regulations, ICH guidance and customer expectations.
- Manage the quality metrics monthly reporting to the global management team and create specific metrics monitoring plans to measure compliance program effectiveness.
- Lead customer quality audits, including audit responses and share voice of customer with extended compliance systems peers from other sites.
- Monitor audit observations, CAPA and investigations for trends, work across sites to create action plans which can be implemented across the sector.
- Actively look for ways to improve the supplier quality management program for service and material suppliers including supplier qualification, risk assessments, performance management and quality agreements.
- Carry our vendor/supplier qualification evaluations including audits of raw materials vendors and service providers to ensure specifications are met.
- Participate and coordinate MHRA inspections, audits and inspections by other regulatory bodies.
- Aid in the harmonization and maintenance of harmonization of the Quality Management Systems across sites, updating procedures, decision trees and compliance tools for the site, as needed.
- To support GMP training activities for the site by providing input into GMP topics.
- Collect, review and report monthly KPI at site level and to Veranova Health Global Quality. Ensure that all action plans are in place and on track for all items at or above the action limit patterning with the applicable functions.
- Provide KPI visibility across site.
- Support QA operations functions (approx. 20-40% of the role) which includes batch disposition as required. Duties may include task associated with
- Batch sheet review and approval of batch sheets
- Support product investigations
- QA activities associated with site packing activities
- Identification of appropriate resulting CAPA’s
- Support the risk assessment processes
- Support site recall process
- Support site change control process
- To participate in change control process
- Participate in the site product quality review process
- To participate in a physical plant standard
- To deputise for the QA Manager when required
- Carries out any other duties within the employee’s skills and abilities whenever reasonably instructed.

**Qualifications**:

- BS or equivalent in Chemistry or related Science
- Expansive experience within a Quality function for an FDA/EMA/MHRA regulated industry
- Have previous experience auditing for cGMP compliance
- Experience with project management and gap assessment projects
- Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
- Experience working in global, cross-functional teams for project execution
- Experience creating metrics for driving continuous improvement
- Experience with drug substance manufacturing

Additional Information