Site Head, Quality – Biologics & Injectables | mid-sized Pharma | N. Carolina | RETAINED SEARCH
Cornerstone Search Group has been retained by a fast-growing and stable mid-sized global pharmaceutical company for a Site Head, Quality (GMP) leadership position. Responsibility will include complete Quality oversight and leadership for a multi-dosage form manufacturing campus, with new manufacturing lines and/or buildings being built to focus on sterile injectables and biologics. You will have the opportunity to grow and build the Quality function as the company has continued growth plans across a rich internal NBE and NCE pipeline as well as a rapidly growing Generics and Complex Generics business.
ATTRACTIVE FEATURES ABOUT THIS OPPORTUNITY:
- High Visibility and High Impact: This is a leadership role for a company that has a strong focus on Quality. You will be only two steps removed from the CEO and play an active leadership role at a critical point in their growth and at a high-profile manufacturing campus site that is being built out.
- Company Culture: We have helped this Company hire a number of people in executive and senior leadership positions and we know firsthand from them that they enjoy this company’s focus on fast, common-sense decision-making as well as the focus on quality.
- Company Stability & Growth: This Company generates significant annual revenues and profits and has been growing quickly and steadily for many years.
- Strong Leadership: Proven executive leadership that is highly engaged, emotionally even-keeled, entrepreneurial, and committed to creating an environment where top-notch people can get the job done right.
SUMMARY OF RESPONSIBILITIES:
- Site leadership and oversight across the Quality Assurance and Quality Control function at a multi-dosage form manufacturing site that is growing with new lines and buildings.
- Ensure GMP compliance in line with the FDA as well as other global regulatory body standards.
- Manage a growing team of direct reports (hiring, training, etc.).
- Design, implement and lead quality strategies, procedures and systems.
- Financial leadership across planning, allocation and management of approved budget.
- Management of systems and resources for validation, ensuring that Quality Systems governed by the operating procedures are monitored and audited regularly and are in a state of compliance as per cGMP and current regulatory requirements.
- Site maintenance and oversight, remaining in constant compliance and audit readiness by ensuring implementation of Quality Systems as per cGMP and meeting all governmental and regulatory compliance requirements.
- Ensure adherence to SOPs relating to stability programs and confirm that any stability failures have been reported as appropriate to site and headquarters management and the respective regulatory agency.
- Devise, review, implement and manage systems within the group to achieve continuous process improvement.
- Ensure the performance of GMP audits by an external source to provide additional auditing controls and suggestions for improvements based on current industry standard.
LOCATION: North Carolina
RELOCATION ASSISTANCE: Yes
DESIRED SKILLS & EXPERIENCES:
- 10-15 years of Quality leadership experience including either sterile injectables or biologics.
- Direct report/people management experience.
- Strong emotional intelligence, integrity, humility, perseverance, a sense of urgency, and the motivation/desire to make an impact for a fast-growing company.
- Experience with starting up a new manufacturing site or manufacturing lines is a plus.
- Experience in a generics environment is a plus.
Tom Fascia | Partner
Corey Ackerman | Sr. Partner
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
6 Campus Drive | Parsippany, NJ 07054 USA
CH: 41 61 508 7010