McKesson Corp is a Fortune 7 company and is one of the largest providers of medicines, pharmaceutical supplies and health information technology (IT) products and services in the United States with revenues of $208.4 billion in 2018. The company was founded in 1833 by John McKesson and Charles Olcott in New York with a focus on importing and wholesaling pharmaceutical products. United by our ICARE values, McKesson's 78,000 employees work together every day to make better care possible for patients around the globe.
As a member of the auditing team the candidate will be responsible for assisting the Supplier Quality Senior Manager in ensuring that licensed pharmaceutical products associated with the Private labels are manufactured, tested and released in compliance with cGMP, US FDA and other applicable regulations. The key function of this role is to minimize the risk to Sunmark/Health Mart label by ensuring a high level of compliance is being adhered to for outsourced work. The candidate will be the lead for auditing and associated activities in our contract manufacturer sites primarily in the US on a regular basis. International travel may be required from time to time.
Lead and conduct quality inspections of outsourced manufacturing facilities, including, but not limited to, solid dose finished product (OTC drugs) Devices, Dietary Supplements, Cosmetics and Consumer products to ensure compliance with cGMP and US FDA regulations
Lead and conduct responsible sourcing inspections of outsourced manufacturing facilities as per company guidelines
Lead and conduct quality inspections of other third-party service providers such as packaging sites, API manufacturing facilities and contract laboratories
Compile inspection reports to include findings, corrections and process improvements
Track corrective actions and planned action agreements from inspections to closure
Participate in continuous evaluation and improvement of all quality aspects at manufacturing sites with particular emphasis on process systems and QMS
Be the point of contact for any regulatory audits associated with the SM/HM label and be able to interact with the agency on any quality issues or queries, for example FDA
Maintain the Quality Agreements between SM/HM and Suppliers to ensure they current and applicable to the sourced products
Carry out business and compliance due diligence exercises
Assist in ensuring compliance policies are managed correctly and efficiently and provide recommendations and direction to relevant parties as necessary
Keep the Management team and colleagues updated on issues and actions which impact the business
Participate in regular team and group meetings
Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required
4+ years relevant work experience
3+ years pharmaceutical manufacturing experience in a similar type role within a progressive multinational organization
Broad knowledge of at least one dosage form e.g. solid dose or devices manufacturing is important
Experience of laboratory, with considerable expertise in at least one pharmaceutical field
Auditing experience required
Solid understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment including ICH guidelines and CFR part 210 / 211 regulations, CFR Parts 800-1299 etc.
Solid understanding of Quality Management Systems
Solid understanding of basic pharmaceutical processes such as a solid dose/device manufacturing process, packaging process, etc.
Additional Skills and Knowledge
Excellent communication skills with ability to communicate at all levels within the organization
Demonstrate ability to lead customers to improve performance or effectiveness; including the ability to influence through effective communication and diplomacy
Ability to compile and made presentations at external sites to senior management level
Ability to work independently and make decisions based on judgement and integrity
Proven analytical skills and ability to transfer findings into well written report formats
Experience / training in problem solving and process improvement methodologies
Ability to work effectively independently and with others to accomplish goals in a challenging environment
Excellent organizational and time management skills
Demonstrates and understands customs and beliefs of various groups or cultures. Understands how these differences affect performance and communication
Educated to degree level or higher, minimum B.Sc. (biological or chemical sciences) or B. Eng, (process and chemical) preferred
General office environment with onsite visits to manufacturing facilities and laboratories requiring travel within the US and limited travel to other foreign locations as required.
We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us. Apply to join our team and help shape the future of healthcare!
McKesson is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAcquisition@mckesson.com . Resumes or CVs submitted to this email box will not be accepted.
Current employees must apply through the internal career site.
Join us at McKesson!
Internal Number: JR0037830
About McKesson Corporation
We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare. If you are passionate about combining a meaningful career with a balanced life, join us on this journey and apply for a job with McKesson today. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.