We are a rapidly growing Global Pharmaceutical Manufacturing Company that is experiencing phenomenal growth due to recent drug product acquisitions. We are in the top 3 fastest growing manufacturing companies in the Lehigh Valley and our company culture is extremely friendly and collaborative.
We offer a very generous base salary, 30.5% bonus potential, and excellent benefits to include: BC/BS medical, free dental, vision, 5% match on 401(k), tuition reimbursement, short & long term disability, life insurance and more.
Purpose of Job:
- Keep Company ‘Quality’ operations aligned with our core values and ethical practices.
- Ensure systems at Company business (sites, CMOs and affiliates) are in synch with current regulations, customers’ expectations and Company quality standards.
- Be accountable for quality products and processes under the scope of Company business.
- Raise early signals to risk of business continuity due to any quality issues. Provide direction on mitigation measures.
- Degree (advanced degree preferred) in Pharmacy, Organic Chemistry or Bio chemistry.
- Capability to direct teams on optimal compliance. Have faced multiple regulatory inspections and have a good liaising experience with regulatory bodies.
- Have been in a prior role overseeing site as a quality lead.
- Leadership Qualities: Rational thinking, decision making, collaborative, ability to find solutions to complex situation, result orientation, good project management skills, and people management.
- Well-organized and detailed oriented professional, with strong verbal and written communication skills in English.
- Need to be ready to live and embrace the values of company.
- Quality professional with 15+ years of hands on experience (in regulated pharma company) with increasing responsibility in a Quality Assurance, Control, especially with Injection and Critical Care product expertise.
- A proved track record in leadership
- Hands on experience implementing quality systems in a GxP environment, and direct experience with FDA and other health authority inspections.
- Extensive knowledge of GxP compliance regulations and industry practices, as well as WHO GMP requirements.
- Ability to absorb, digest, interpret, and relate detailed scientific, quality, and regulatory information.
- Comprehensive knowledge of Quality, Regulatory Affairs and Compliance issues and standards related to pharmaceuticals including a strong understanding of the CFR, FDA, ICH and cGMPs regulations. International regulatory experience desirable
- API and medical device experience highly desirable.
- ISO 13485/QSR Regulations and BSI Notified Body Audits.
- Demonstrated ability to establish a world-class Quality culture and Quality systems.
- Track record of effective management and development of Quality Assurance professionals.
- Demonstrated skills in achieving results and managing others to achieve corporate, site, and departmental objectives.
- Demonstrated experience in making decisions to resolve the most complex problems and providing sound compliance advice and direction.
- Demonstrated successful interdisciplinary collaboration in a team setting.
- Demonstrated ability to assess the state of current business and QA operations for Quality Systems to identify and recommend future state, improvements, and to implement action plans.
- Demonstrated competence to resolve complex and diverse problems with decision making responsibility that has a major impact within QA and/or with functional groups
- Demonstrated experience leading strategic development and successful execution of plans and initiatives for addressing complex and diverse QA matters with minimal management oversight. Contributes to the identification and implementation of long-term business planning strategies, assuring quality is taken into consideration.
- Demonstrated ability to develop quality assurance professionals to both lead and manage a functional quality assurance unit.
- Demonstrated experience in hosting and facilitating regulatory agency inspections with successful outcomes.
- Excellent written & verbal communication skills, good presentation and influencing skills
- The ability to multi- task in a fast paced, high pressure environment is essential.
We are a Global leader in the Pain Management sector and experiencing phenomenal growth due to recent acquisitions.
Location/Region: Bethlehem, PA (US)